Biomarkers of Food Intake Using a Cross-over Feeding Study

NCT ID: NCT03855098

Last Updated: 2021-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-12-20

Brief Summary

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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.

Detailed Description

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For biomarker discovery a 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). 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 . Standard portions of the test food will be eaten on each occasion. Between the visits, participants will consume their habitual diet.

The samples will be analysed using the metabolomics platforms LC-MS and NMR spectroscopy. Both NMR and LC-MS data generated will undergo statistical analysis such as principal component analysis (PCA) and supervised analysis such as partial least squares-discriminant analysis (PLS-DA). Validation of such models will be performed using permutation testing.

Conditions

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Diet Habit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fruit and Vegetable biomarkers

Each participant will consume the test foods over different weeks

Group Type OTHER

Biomarkers of Fruit and Vegetable Intake

Intervention Type 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.

Interventions

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Biomarkers of Fruit and Vegetable Intake

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Smokers
2. Diagnosed health condition (chronic or infectious disease)
3. Taking medication (oral contraceptive pill is allowed)
4. Pregnant, lactating
5. Allergies/intolerances to any of specified test foods
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Lorraine Brennan

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorraine Brennan, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Locations

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University College Dublin

Dublin, Dublin 4, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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UCD_123_2019

Identifier Type: -

Identifier Source: org_study_id

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