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Biomarkers of Food Intake Using a Cross-over Feeding Study

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University College Dublin

Status

Completed

Conditions

Diet Habit

Treatments

Other: Biomarkers of Fruit and Vegetable Intake

Study type

Interventional

Funder types

Other

Identifiers

NCT03855098
UCD_123_2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Fruit and Vegetable biomarkers
Other group
Description:
Each participant will consume the test foods over different weeks
Treatment:
Other: Biomarkers of Fruit and Vegetable Intake

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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