Dietary Biomarkers 2.0: From Potential Towards Implementation.

Healthy Clinical Trial

Official title:

Dietary Biomarkers 2.0: From Potential Towards Implementation. A Randomized Controlled Trial to Assess Dose-response Relationships for Dietary Biomarkers of Selected Foods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05073523
• Other study ID #: ChalmersUT
• Status: Completed
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: November 2022
• Source: Chalmers University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Diet
All intervention meals consist of five different food groups including fruits, vegetables, legumes, dairy products, and whole grains. Differences in the proportion of these foods in Meal A-C is tested.

Locations

Country	Name	City	State
Sweden	University of Gothenburg, Department of Food and Nutrition and Sport Science	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Chalmers University of Technology

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma concentrations of dietary candidate biomarkers (daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane)	Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over the 24h period).	24 hours
Primary	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)	Difference in the plasma concentrations of diet specific biomarkers comparing before (baseline) and after intervention meal (average plasma concentration over the 24 h period).	24 hours
Primary	Plasma concentration-time profile over 24h (AUCs) of dietary biomarker candidates ( daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane)	Differences in plasma AUCs between the three intake levels for each biomarker candidate	24 hours
Primary	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	Differences in plasma AUCs between the three intake levels.	24 hours
Secondary	Gut microbiome	Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention meals.	4 days
Secondary	Plasma metabolites	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.	4 days
Secondary	Urine metabolites	Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect the specific foods included in study meals.	24 hours
Secondary	Fecal concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane	Evaluate new simple sampling techniques using faecal swabs.	4 days
Secondary	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)	Evaluate new simple sampling techniques using fecal swabs.	4 days
Secondary	Blood concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane	Evaluate new simple sampling techniques using dried blood spots.	4 days
Secondary	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)	Evaluate new simple sampling techniques using dried blood spots.	4 days
Secondary	Urine concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane	Evaluate new simple sampling techniques using dried urine spots.	4 days
Secondary	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	Evaluate new simple sampling techniques using dried urine spots.	4 days