Dietary Biomarkers 2.0: From Potential Towards Implementation.
- Conditions
- Healthy
- Interventions
- Other: Diet
- Registration Number
- NCT05073523
- Lead Sponsor
- Chalmers University of Technology
- Brief Summary
The aim of this project is to fill a gap in the translation of dietary biomarkers as unbiased measures of food intake from high-end academic research into a methodology that ca be easily applied across academic, public and private health sector to objectively assess specific dietary intakes at group and individuals' level to a) improve understanding of diet and health relationships b) address compliance in dietary intervention studies and c) assess individuals' dietary intakes to guide their eating towards improved health. The study will be carried out as a three-way cross-over design with three different meal compositions (A, B, C) where each meal is provided 3 times per day during four days per meal. A wash-out period of 7 days where participants consume their habitual diet is implemented and a 3-day run-in before the study meal intervention. The first day of study meal intervention includes postprandial measurements during 8 hours.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- Men and women
- Age 18-80 years
- Body mass index (BMI) 18.5-30 kg/m2
- Fasting glucose ≤ 6.1 mmol/l
- Low density lipoprotein (LDL), Cholesterol ≤ 5.30 mmol/L
- Triglycerides ≤ 2.60 mmol/L
- Signed informed consent
- Food allergies or intolerances preventing consumption of any products included in the study.
- Strict vegetarian or vegan, participants must be able to eat dairy products as it is included in the study diet.
- Unable to sufficiently understand written and spoken Swedish to provide written consent and understand information and instructions from the study personal.
- Unable to satisfactorily complete the 3-day weighted food records.
- Continuous/daily use of medication.
- Pregnant, lactating or planning a pregnancy during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Meal B Diet Diet: meal proportion 2 Meal C Diet Diet: meal proportion 3 Meal A Diet Diet: meal proportion 1
- Primary Outcome Measures
Name Time Method Plasma concentrations of dietary candidate biomarkers (daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane) 24 hours Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over the 24h period).
Plasma concentration-time profile over 24h (AUCs) of dietary biomarker candidates proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B 24 hours Differences in plasma AUCs between the three intake levels.
Plasma concentrations of dietary biomarker candidates (proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B) 24 hours Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over the 24 h period).
Plasma concentration-time profile over 24h (AUCs) of dietary biomarker candidates ( daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane) 24 hours Differences in plasma AUCs between the three intake levels for each biomarker candidate
- Secondary Outcome Measures
Name Time Method Fecal concentrations of diet specific biomarkers proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B) 4 days Evaluate new simple sampling techniques using fecal swabs.
Urine metabolites 24 hours Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect the specific foods included in study meals.
Gut microbiome 4 days Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention meals.
Plasma metabolites 4 days Untargeted metabolomics will be performed using established methods for plasma. Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect the specific foods included in study meals. Baseline compared with after intervention meals.
Fecal concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane 4 days Evaluate new simple sampling techniques using faecal swabs.
Blood concentrations of diet specific biomarkers proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B 4 days Evaluate new simple sampling techniques using dried urine spots.
Blood concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane 4 days Evaluate new simple sampling techniques using dried blood spots.
Blood concentrations of diet specific biomarkers proline betaine, 4-hydroxyphenylacetic acid, 4-hydroxyphenylpyruvate, indole-3-lactic acid, pipecolic acid, s-methylcysteine, avenacoside-A and avenacoside-B) 4 days Evaluate new simple sampling techniques using dried blood spots.
Urine concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane 4 days Evaluate new simple sampling techniques using dried urine spots.
Trial Locations
- Locations (1)
University of Gothenburg, Department of Food and Nutrition and Sport Science
🇸🇪Gothenburg, Sweden