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The Effect of Nordic Recommended Diet on the Features of Metabolic Syndrome - Multicentre Study (SYSDIET)

SYSDIET

SYSDIET (Systems biology in controlled dietary interventions and cohort studies) is one of the three centres in the NCoE Food, Nutrition and Health, 2007-2011. It consists of 12 partners from five Nordic countries working on multidisciplinary fields of science related to nutritional biology. The main objective of SYSDIET is to reveal mechanisms by which Nordic foods and diets could be modified to promote health and prevent insulin resistance, type 2 diabetes and cardiovascular diseases, all of which being connected to metabolic syndrome. Furthermore, the aim is to build up a Nordic platform for cohort studies and carefully conducted multi-centre dietary intervention studies, where novel nutritional systems biology tools can be applied besides human studies also in animal and cell culture studies. The aim of the SYSDIET consortium is to carry out a controlled, randomized dietary intervention study in persons with features of metabolic syndrome to find out the effects of a healthy Nordic food on major abnormalities in metabolic syndrome.

Start date

2009-10-07 00:00:00

Endpoint

Assessing the impact of the healthy Nordic diet on major abnormalities associated with metabolic syndrome on people with features of metabolic syndrome.

Objectives

To reveal mechanisms by which Nordic foods and diets could be modified to promote health and prevent insulin resistance, type 2 diabetes and cardiovascular diseases, all of which being connected to metabolic syndrome.

Conclusion

Conclusions of 8 manuscripts: 1. Healthy Nordic diet improved lipid profile and had a beneficial effect on low-grade inflammation. 2. A healthy Nordic diet transiently modified the plasma lipidomic profile, specifically by increasing the concentrations of antioxidative plasmalogens and decreasing insulin resistance-inducing ceramides. 3. A Dietary Biomarker score combining multiple biomarkers can effectively assess compliance in dietary RCTs, as demonstrated by more substantial improvements in cardiometabolic risk factors among compliant participants and an increased difference between the intervention and control groups. 4. Benefits of a healthy diet may be mediated by improved mitochondrial function and reduced inflammation. 5. Increased proportion of whole grain rye, reflected by a biomarker, in the diet is associated with favorable blood lipid outcomes, a relationship that should be further investigated. 6. Plasma and urine metabolite profiles from SYSDIET reflected good compliance with dietary recommendations across the region. The scores of metabolites characterizing the diets associated with outcomes related with cardio-metabolic risk. 7. PAB plasma concentrations were associated with fasting insulin, inflammation, and lipids and were significantly increased with adoption of the HND. 8. A healthy Nordic diet reduces inflammatory gene expression in SAT compared with a control diet independently of body weight change in individuals with features of the metabolic syndrome.

Exclusion

- Fasting plasma glucose > 7.0 mmol/l - Fasting plasma triglycerides > 3.0 mmol/l - Fasting plasma total cholesterol > 6.5 mmol/l - Blood pressure > 160/100 mmHg - Preceding weight change of 5% or more or active weight loss during preceding 6 months - Any disease or condition that may hamper the successful participation of the intervention: liver disease, kidney disease, diabetes (both type 1 and type 2), thyroid disease (Newly found unstabilized disease), Myocardial infarction within previous 6 months - Alcohol abuse (> 40 g/day) - Oral corticosteroid therapy - Severe psychiatric disorders - Cancer under treatment - Coeliac disease - Exceptional diets (Atkin's, vegan, allergies to fish or cereals, other extensive allergies) - Binge eating - Unwillingness to discontinue the use of fish and vegetable oil or stanol and sterol ester supplements or products

Inclusion

- Age 30-65 years old - BMI 27-38 kg/m2 - two + other IDF criteria for metabolic syndrome - Anti-hypertensives and lipid-lowering medication are allowed

Inclusion

- Age 30-65 years old - BMI 27-38 kg/m2 - two + other IDF criteria for metabolic syndrome - Anti-hypertensives and lipid-lowering medication are allowed

Country

Consortium

SYSDIET

Published (PubMed)

25527767; 31504116; 35007813; 25340768; 26962194; 25080537; 23398528; 30964598

Researchdesign

Research design

Blinding

Blinding method

Parallel

Research design description

Recruited persons will start the study by following their conventional diet for one month as a run-in period. After that subjects will be randomly assigned into Experimental- or Control-diet-group for 6 months. Experimental diet is rich in whole grain products, berries, fruits, vegetables and fish, and its fat intake is modified according to current Nordic recommendations. Control diet is based on the current information of the mean dietary intake and food consumption. The diets will be realized according to eating habits in each Nordic country.

Recruitment

Recruitment start year

2009

Recruitment end year

2010

Number of volunteers

200

Number of volunteers terminated

167

Factors

Number of treatments

Number of factors

Number of arms

Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults

M210, MEDA

The purpose of this randomized, controlled, cross over single meal study is to investigate the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for their intake. The results from this project will increase our knowledge about nutritional value of dairy proteins, which is necessary to decide whether dairy products can be recommended for prevention of weight related bone loss.

Start date

2012-11-01 00:00:00

Endpoint

plasma and urine metabolomes, serum and urine C-terminal carboxy-terminal collagen crosslinks (CTX), serum osteocalcin (sOC), serumtarthritis-resistant acid phosphatase (s-TRAP), and urine deoxypyridinoline crosslink(uDPD)

Objectives

The purpose of the project is to investigate the importance of an acute intake of a diet rich in meat and dairy proteins on bone metabolism, as well as metabolic profile in urine and plasma in obese people

Conclusion

for the biomarkers: Although some of the markers resulted not being specific of meat dairy and meat intake, often it is not a single marker itself, but a specific profiles composed of a range of molecules that will fulfill the needed criteria to qualify as biomarkers of food intake. Therefore, the identified markers could be used in combination to provide a better estimation of meat and dairy intake, taking into consideration their excretion kinetics to assure a total collection of the urine in the required amount of time. Other conclusions are are not made yet

Exclusion

• Physical activity more than 10 hours/week • Smoking • Diagnosed osteoporosis in at least one parent • Dietary supplements and vitamin pills (during the entire trial and 2 months before the start) • Vegetarians and vegans • Lactose intolerance • Women who are pregnant, breastfeeding or post-menstrual • Regular intake of medication • Chronic diseases (including osteoporosis, cancer, diabetes, cardiovascular disease and mental disorders) • Participation in other clinical trials that may affect the results of this trial • Donation of blood up to 3 months before the start of the trial • Hypersensitivity to paraaminobenzoic acid (PABA) (included as a sun protective factor in sunscreens) • Unable to comply with the procedures prescribed by protocol

Inclusion

• Healthy men and women 18-50 years • BMI 25-40 kg/m2

Inclusion

• Healthy men and women 18-50 years • BMI 25-40 kg/m2

Country

Denmark

Consortium

Not ready for sharing

Published (PubMed)

Researchdesign

Research design

Blinding

Blinding method

Crossover

Research design description

The MEDA trial is a randomized, crossover intervention trial which aims to investigate acute effects of high intake of dairy protein (intervention A) compared to meat protein (intervention B). The trial includes 17 healthy adult women and/or men who are randomized to intervention A and B in a random order. Each intervention includes a morning meal test which is carried out at the Department of Sports and Nutrition, as well as a follow-up period which starts immediately after completion of the meal test and ends in the morning of the following day (Table 1). In intervention A, subjects must consume a test meal rich in dairy proteins and in intervention B, subjects must consume a test meal rich in meat proteins. After consuming each meal test, subjects will be asked not to consume animal proteins until the next morning. Each intervention lasts one day and is separated from each other by a minimum of a 7-day period. That is the test subjects must come twice to the Department of Sports and Nutrition for visits 1 and 2. During both intervention days, fasting and postprandial blood samples are taken, which are analyzed for the desired parameters. Urine is also collected for one day before each intervention (so-called run-in day), urine collection during the first 1-2 hours after each morning meal test, urine collection during the last time of the meal test (i.e. hour 3-4 ), and collection of remaining urine until 7 the following day (so-called follow-up period). One day before each intervention, the subjects will be asked not to eat fish and fish products in their diet (run-in day). Due to the nature of the trial, intervention A and B are not blinded. If all test subjects are not recruited before the start of the project, the randomization of test subjects will take place on an ongoing basis on the basis of a randomization plan which is drawn up before the start of the recruitment of test subjects.

Recruitment

Recruitment start year

2012

Recruitment end year

2013

Number of volunteers

Number of volunteers terminated

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Number of treatments

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Discovery of Urinary Biomarkers of Spinach Consumption Using Untargeted LC-MS Metabolomics in a Human Intervention Trial

Spinach Biomarkers

Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively. The study will be conducted as a randomised, controlled, 2-way crossover study in 24 participants (12 in each group), randomized to two sequences (1-2, 2-1) of interventions with a more and a less bio-accessible spinach preparation. The serum, chylomicron and fecal/effluent levels of lutein and beta-carotene will be determined.

Start date

2015-01-01 00:00:00

Endpoint

Serum concentration of lutein and beta-carotene: Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.

Objectives

The study aimed 1) to review previous work on biomarkers of spinach intake; 2) to find and characterize putative BFIs and biomarkers of effect after a challenge with spinach; 3) to investigate the effect of ingested spinach leaf size as well as effects of the length of the large bowel on the markers.

Conclusion

We propose structures for three candidate spinach intake biomarkers; these markers will need further validation in independent studies.

Exclusion

- Intestinal diseases (among healthy controls), systemic infections, psychiatric disorders, metabolic diseases (incl. diabetes), and any clinical condition/circumstance which assessed by the study official makes the person unfit for participation in the trial. - Patients diagnosed with short bowel syndrome (SBS). - Chronic or frequent use of medication. Primarily consumption of drugs with known effect/side effects on fat absorption. Further, anticoagulants (Marevan) and systemic treatment with glucocorticoids. - Have or have had a drug addiction - Smokers - Alcohol consumption beyond the recommended (7/14 units per week for women/men, respectively) - Intake of vitamins or other supplements (3 months before the study and during the study) (healthy controls). Subjects from the patient group included only with stable intake of dietary supplements through the last 3 months. - Sampling or donation of larger amount of blood e.g. as blood donors or to other scientific experiments from 3 months before the study until its completion. - allergy or intolerance to any of the foods included in the study. - Women who are nursing, pregnant or planning pregnancy - Not able to comply with the procedures protocol. - Macular degeneration to a degree greeter than or equal to a surface area with one or more drusen larger than 125 microns in diameter in at least one eye. - Cataracts, macular- or other ocular disease, preventing depiction of xanthophyll pigment.

Inclusion

- Healthy adults (18-80 years old) - Body Mass Index (BMI) between 18,9-28 - Normal fasting blood glucose (BS) (1,9-5,6 mmol/L) - Tolerates: Potatoes, rice, chicken, meat (non vegan/vegetarian).

Inclusion

- Healthy adults (18-80 years old) - Body Mass Index (BMI) between 18,9-28 - Normal fasting blood glucose (BS) (1,9-5,6 mmol/L) - Tolerates: Potatoes, rice, chicken, meat (non vegan/vegetarian).

Country

Denmark

Consortium

Not ready for sharing

Published (PubMed)

35072987

Researchdesign

Research design

Blinding

Blinding method

Crossover

Research design description

A randomized, controlled, open-labeled, cross-over trial was performed. Each enrolled subject was randomized to the sequence of two kinds of processed spinach, either minced before whole leaf spinach or vice versa. Spinach was provided on the test day and every second day for a 14 days period. Randomization to the sequence was done by flipping a coin by a person not involved in the project. The two study periods with the same duration were divided by a 2-week wash-out period to avoid any carry-over effect. Each experimental period with a total of 17 days was subdivided into three parts: -48 to 0 h defined as the run-in period, 0–24 h (after the first meal), defined as the test day, and 24 h–2 weeks defined as the follow-up period.

Recruitment

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Carotenoid Absorption and Metabolism From Green-leafy Vegetable Matrices - a Explorative Study in Short-bowel Patients and Healthy Controls - The "Popeye-study"

Carotenoids and Macular pigment optical density Baseline data

Reduced absorption capacity in patients with intestinal resections (IR) could result in malabsorption of fat-soluble components like carotenoids, which are of clinical interest in relation to visual health. In this case cohort, we investigated the association between IR and serum lutein, zeaxanthin, β-carotene and macular pigment optical density, when compared with healthy controls. Ten patients with IR and twelve healthy controls were included in the study. Baseline characteristics were comparable between groups, except for higher serum TAG (P < 0·05) and shorter bowel length (P < 0·0001) in the group with IR. Serum lutein, zeaxanthin, β-carotene and macular pigment optical density were >15 % lower in the patient group compared with healthy controls (P < 0·05, adjusted for age) and, in the case of serum lutein and zeaxanthin, also for dietary intake of carotenoids. Results suggest that for a test of macular carotenoid supplementation, subjects with a potentially clinically significant carotenoid deficit could be recruited among patients with IR.

Start date

2015-01-01 00:00:00

Endpoint

Serum concentration of lutein and beta-carotene. Difference in serum concentration of lutein and beta-carotene between baseline and the end of each intervention period.

Objectives

Absorption and metabolism of carotenoids from two types of spinach preparations will be investigated in two study groups, short bowel/ileostomy and healthy, respectively. The study will be conducted as a randomised, controlled, 2-way crossover study, using the baseline data in 24 participants (12 in each group). The serum, chylomicron and fecal/effluent levels of lutein and beta-carotene will be determined.

Conclusion

The present study found lower serum carotenoids and lower macular pigment optical densities in patients with intestinal resection than in healthy subjects. While there is no certain knowledge about the effects of having low serum carotenoid levels, there are important indications that low retinal carotenoid levels may have a deleterious effect on retinal health. Our findings suggest that patients with intestinal resection or even short bowel disease should be examined, in a scientific context, for signs of poor retinal health. Our results should be validated in larger studies.

Exclusion

Inclusion

Healthy adults (18-80 years old) Body Mass Index (BMI) between 18,9-28 Normal fasting blood glucose (BS) (1,9-5,6 mmol/L) Tolerates: Potatoes, rice, chicken, meat (non vegan/vegetarian).

Inclusion

Healthy adults (18-80 years old) Body Mass Index (BMI) between 18,9-28 Normal fasting blood glucose (BS) (1,9-5,6 mmol/L) Tolerates: Potatoes, rice, chicken, meat (non vegan/vegetarian).

Country

Denmark

Consortium

Not ready for sharing

Published (PubMed)

29430299

Researchdesign

Research design

Blinding

Blinding method

Crossover

Research design description

The recruitment methodology is described in detail in the study by JN Eriksen et al. (unpublished results) and in the Supplementary material. In brief, we recruited twelve healthy subjects and ten patients with intestinal resections (140–350 cm small intestine left) from a pool of volunteers and from the Department of Gastroenterology of the Rigshospitalet, respectively, to participate in a cross-over study of carotenoid supplementation. The data presented here are from the baseline examination. Subjects were matched by age (±5 years) and sex.

Recruitment

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Effect of Whole Barley Bread on the Risk of Metabolic Diseases and Other Health Effects

Whole Barley

The study aimed to compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status.

Start date

2015-09-14 00:00:00

Endpoint

The primary outcomes of this study are evaluation of LDL-c, insulin and glucose levels evaluated by analysis of fasting blood samples. Furthermore, selected measures to evaluate SCFA level in blood is to be evaluated.

Objectives

To compare the metabolic effects of consuming whole barley bread and whole wheat bread, in healthy subjects. Also, to investigate the effect of whole grain flour on mineral status. The following hypotheses will be investigated: 1) A WBB-based dietary intervention beneficially contributes to the reduction of the risk of CVD and T2D through the improvement of glcaemia in healthy subjects compared to a WWB-based dietary intervention. 2) WBB improves subjective lipid profile compared to WWB based-diet. 3) Improvement in postprandial glycaemia and insulinaemia is linked to betaglucan content in WBB. 4) Whole grain bread may affect mineral status in the human body.

Conclusion

not there yet

Exclusion

- Wheat/gluten or barley intolerance - Smoking on a daily basis - Lactating (or lactating within 6 weeks prior to study start), pregnant (or pregnant within 3 months prior to study start) or wish to become pregnant during the study - Diagnosed with any form of diabetes or CVD - Reported chronic GI disorders - Taking dietary supplements during or one month prior to the study - Lack of cooperation and adherence to the protocol - Use of prescription medication will be evaluated on an individual basis - Blood donation within 3 months prior to study start or during the study - Participation in other clinical trials

Inclusion

- Like and tolerate wheat/ barley bread products. - Age: 20 - 53 years - Body mass index (BMI): 23 - 30 kg/m 2 - Weight stable (<3 kg weight change during the last 6 months) - Apparently healthy

Inclusion

- Like and tolerate wheat/ barley bread products. - Age: 20 - 53 years - Body mass index (BMI): 23 - 30 kg/m 2 - Weight stable (<3 kg weight change during the last 6 months) - Apparently healthy

Country

Denmark

Consortium

Not ready for sharing

Published (PubMed)

Researchdesign

Research design

Blinding

Blinding method

Crossover

Research design description

The intervention is designed as a randomized, cross over trial of 3-weeks duration. A total of 14 participants will be included in the study. In one period subjects will receive WBB bread; in the second period, subjects will receive WWB bread. This bread is based on the recipe of Egyptian Baladi bread but formed in Danish buns form. Participants will incorporate this bread into their normal habitual diet with regard to the study restrictions about other cereal food products. At the beginning and end of each intervention period blood will be drawn and urine collected and stored for later analysis.

Recruitment

Recruitment start year

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Acute effects of light and dark roasted coffee on glucose tolerance: a randomized, controlled crossover trial in healthy volunteers

M217 Kaffe 2

Epidemiological evidence suggests that coffee consumption is associated with a lower risk of type 2 diabetes. Coffee contains caffeine and several other components that may modulate glucose regulation. The chlorogenic acids (CGA) in coffee have been indicated as constituents that may help to normalize the acute glucose response after a carbohydrate challenge. The aim of this study was to investigate whether two coffee beverages that differ in CGA content due to different roasting degrees will differentially affect glucose regulation. Methods In a controlled crossover trial, 11 healthy fasted volunteers consumed 300 mL of either light (LIR) or dark (DAR) roasted coffee, or water, followed 30 min later by a 75-g oral glucose tolerance test (OGTT). Blood samples were drawn at baseline, 30, 60, and 120 min. Differences in glucose and insulin responses and insulin sensitivity index (ISI) were analyzed. The CGA and caffeine contents in the coffees were analyzed using UPLC-MS/MS. Results No differences in glucose area under the curve (AUC) were found between treatments. Glucose concentrations were higher at 60 min after ingestion of DAR compared with water, while ingestion of LIR showed similar glucose concentrations as ingestion of water. Insulin AUC was higher after ingestion of DAR compared with water, and both coffees raised insulin concentrations and reduced ISI compared with water, with no difference between the two coffees.

Start date

2024-02-27 00:00:00

Endpoint

. The primary outcome was to investigate the blood glucose response during the three treatments by comparing AUCs.

Objectives

The chlorogenic acids (CGA) in coffee have been indicated as constituents that may help to normalize the acute glucose response after a carbohydrate challenge. The aim of this study was to investigate whether two coffee beverages that differ in CGA content due to different roasting degrees will differentially affect glucose regulation.

Conclusion

Two coffees with different CGA contents did not differentially affect glucose or insulin responses during an OGTT, but both increased the insulin response compared with water.

Exclusion

Exclusion criteria were systemic infections, psychiatric or metabolic disorders, known food allergies or intolerances related to the products used in the study, ongoing or former drug abuse, high intake of alcohol, pregnancy or ongoing planning of pregnancy, vegetarianism or veganism, participation in other scientific studies during the study period, and blood donation during— or in the month leading up to—the study period.

Inclusion

Healthy volunteers aged 18–65 years with a body mass index (BMI) of 18.0–30.0 kg/m2 and with no known diseases were eligible for inclusion. Habitual coffee consumption was not a requirement for participation, and that information was therefore not collected. However, it was required that the participants felt comfortable drinking black, unsweetened coffee in the amount of time specified in the study design.

Inclusion

Country

Denmark

Consortium

FoodBAll

Published (PubMed)

10.1007/s00394-015-1032-9

Researchdesign

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A personal microbiome-dependent glucose response in healthy young volunteers: a meal test study

MIGLUCOSE

The gut microbiome has combined with other person-specific information, such as blood parameters, dietary habits, anthropometrics, and physical activity been found to predict personalized postprandial glucose responses (PPGRs) to various foods. Yet, the contributions of specific microbiome taxa, measures of fermentation, and abiotic factors in the colon to glycemic control remain elusive. We tested whether PPGRs 60 min after a standardized breakfast was associated with gut microbial α-diversity (primary outcome) and explored whether postprandial responses of glucose and insulin were associated with specific microbiome taxa, colonic fermentation as reflected by fecal short-chain fatty acids (SCFAs), and breath hydrogen and methane exhalation, as well as abiotic factors including fecal pH, fecal water content, fecal energy density, intestinal transit time (ITT), and stool consistency. A single-arm meal trial was conducted. A total of 31 healthy (24 female and seven male) subjects consumed a standardized evening meal and a subsequent standardized breakfast (1,499 kJ) where blood was collected for analysis of postprandial glucose and insulin responses. PPGRs to the same breakfast varied across the healthy subjects. The largest inter-individual variability in PPGRs was observed 60 min after the meal but was not associated with gut microbial α-diversity. In addition, no significant associations were observed between postprandial responses and specific taxa of the gut microbiome, measures of colonic fermentation, ITT, or other abiotic factors. However, fasting glucose concentrations were negatively associated with ITT, and fasting insulin was positively associated with fasting breath hydrogen. In conclusion, the gut microbiome, measures of colonic fermentation, and abiotic factors were not shown to be significantly associated with variability in postprandial responses, suggesting that contributions of the gut microbiome, colonic fermentation, and abiotic factors to PPGRs may be subtle in healthy adults.

Start date

2018-10-12 00:00:00

Endpoint

Postprandial plasma glucose at 60 min as a function of gut microbial richness

Objectives

Conclusion

Exclusion

Inclusion

Country

Denmark

Consortium

Published (PubMed)

Researchdesign

Research design

Blinding

Blinding method

Research design description

single-arm meal study

Recruitment

Recruitment start year

2018

Recruitment end year

2018

Number of volunteers

Number of volunteers terminated

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