Biomarkers of Food Intake Using a Cross-over Feeding Study

NCT03855098 | Completed

• 1 other identifier: UCD_123_2019
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of dietary intake is key for understanding the links between diet and health. Here, researchers will study molecules in urine samples to give them an insight into what people have eaten. These new molecules are called dietary biomarkers. This study will help to identify new molecules that can act as biomarkers of commonly consumed foods. These can then be used in the assessment of diet, identification of diet-related diseases and used how to explain how a dietary intervention (programme) will work, thereby adding to scientific knowledge.

Conditions

Diet Habit

Keywords

Metabolomics; dietary biomarkers; personalized nutrition

Outcome Measures

Primary Outcomes (1)

• Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.

  A number of biomarkers will be identified for the test foods. These biomarkers will be measured using LC/MS and NMR spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.

  2, 4 and 6 hours post consumption of the test food. Urine samples are taken postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomaker identification studies.

Study Arms (1)

Fruit and Vegetable biomarkers

OTHER

Each participant will consume the test foods over different weeks

Other: Biomarkers of Fruit and Vegetable Intake

Interventions

Biomarkers of Fruit and Vegetable Intake OTHER

Cross-over study where participants will visit the Human Intervention Centre (in UCD) on 3 occasions (3 study days) with a minimum one week between each visit. The order of consumption of the test foods will be randomized. The test foods are mixed vegetables (spinach and lettuce), green beans and mixed berried (strawberries and blueberries). The following definition of portion sizes will be used; green beans (120g), lettuce (20g), spinach (90g), strawberries (96g) and blueberries (75g). For each study day, the participants will arrive fasting and provide a urine sample (0h sample). For 24h prior to the study day participants will avoid the test foods. Participants will consume the food and urine samples will be taken at 2, 4, 6 and 24 h post consumption.

Fruit and Vegetable biomarkers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18-50 years old
• BMI\<30.

You may not qualify if:

• Smokers
• Diagnosed health condition (chronic or infectious disease)
• Taking medication (oral contraceptive pill is allowed)
• Pregnant, lactating
• Allergies/intolerances to any of specified test foods

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

University College Dublin

Dublin, Dublin 4, D4, Ireland

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Lorraine Brennan, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Each participant is asked to eat a test food (mixed vegetables (spinach and lettuce), green beans and mixed berries (strawberries and blueberries). They are asked for urine samples for up to 6 hours after eating each food. They are also asked for a urine sample one day after eating the foods. The samples are then analysed for dietary biomarkers.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 26, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 20, 2020
• Last Updated: May 5, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)