Clinical trial NCT03855098: Biomarkers of Food Intake Using a Cross-over Feeding Study
Official title: Identification of New Dietary Biomarkers Using a Cross-over Feeding Study Among 25 Individuals in University College Dublin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Keywords: Metabolomics
dietary biomarkers
personalized nutrition
Lead sponsor: University College Dublin
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
state: Dublin 4
Study officials:
affiliation: University College Dublin
name: Lorraine Brennan, PhD
role: PRINCIPAL_INVESTIGATOR
References: