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Completed

NCT Number: NCT05073523

Dietary Biomarkers 2.0: From Potential Towards Implementation.

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Plasma concentrations of dietary candidate biomarkers (daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane)

    Time frame: 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).

  2. 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)

    Time frame: 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).

  3. Plasma concentration-time profile over 24h (AUCs) of dietary biomarker candidates ( daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane)

    Time frame: 24 hours

    Differences in plasma AUCs between the three intake levels for each biomarker candidate

  4. 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

    Time frame: 24 hours

    Differences in plasma AUCs between the three intake levels.

Secondary outcomes

  1. Gut microbiome

    Time frame: 4 days

    Fecal samples will analyzed for composition of the gut microbiome, baseline compared with after 4 days of intervention meals.

  2. Plasma metabolites

    Time frame: 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.

  3. Urine metabolites

    Time frame: 24 hours

    Analyzed exploratorily using untargeted metabolomics to find potential biomarker panels that reflect the specific foods included in study meals.

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

    Time frame: 4 days

    Evaluate new simple sampling techniques using faecal swabs.

  5. 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)

    Time frame: 4 days

    Evaluate new simple sampling techniques using fecal swabs.

  6. Blood concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane

    Time frame: 4 days

    Evaluate new simple sampling techniques using dried blood spots.

  7. 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)

    Time frame: 4 days

    Evaluate new simple sampling techniques using dried blood spots.

  8. Urine concentrations of diet specific biomarkers daidzein, genistein, hesperetin, naringenin, phloretin, kaempferol, 2-thiothiazolidine-4-carboxylic acid, sulforaphane

    Time frame: 4 days

    Evaluate new simple sampling techniques using dried urine spots.

  9. 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

    Time frame: 4 days

    Evaluate new simple sampling techniques using dried urine spots.

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 11, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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