Dietary Biomarkers 2.0: From Potential Towards Implementation.

NCT05073523 | Completed

• 1 other identifier: ChalmersUT
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (9)

• Gut microbiome

  4 days

• Plasma metabolites

  4 days

• Urine metabolites

  24 hours

• Fecal concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane

  4 days

• 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

Study Arms (3)

Meal A

OTHER

Diet: meal proportion 1

Other: Diet

Meal B

OTHER

Diet: meal proportion 2

Other: Diet

Meal C

OTHER

Diet: meal proportion 3

Other: Diet

Interventions

Diet OTHER

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.

Meal A; Meal B; Meal C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chalmers University of Technology: lead

Study Sites (1)

University of Gothenburg, Department of Food and Nutrition and Sport Science

Gothenburg, Sweden

Location

MeSH Terms

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Rikard Landberg, Dr

  Chalmers University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 11, 2021
• Study Start: September 27, 2021
• Primary Completion: October 28, 2022
• Study Completion: October 28, 2022
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)