Health TrialsbyHealthPanel

The Precision Nutrition New York Study

ConditionsBody Composition ChangesBody Weight Changes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorCornell University

About this trial

Dietary fiber has been shown to have beneficial effects on human health through its impact on microbes present in the gut. However, these effects can vary between individuals, and everyone may not reap the same health benefits by eating the same sources of fiber. Factors predicting how an individual's gut microbes as well as the beneficial metabolites produced by these microbes change in response to different sources of fiber would be helpful in developing precision nutrition approaches that maximize the benefits of dietary fiber. The objective of this study is to evaluate candidate predictors of gut microbiota response to fiber sources from either whole grains or fruits and vegetables.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age is between 21-50 years

BMI is between 25-30. You can check your BMI here: https://www.cdc.gov/bmi/adult-calculator/index.html

Must be able to have height, weight, waist, and hip circumference, and body composition measured during the study

Must be able to provide saliva samples.

Disqualifiers

Electronic medical implant, for example, a pacemaker.

An existing, UNTREATED, thyroid condition.

Use of systemic antibiotics (intravenous injection, intramuscular, or oral) within the last 4 months.

An acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).

Trial design

Design model

Crossover

Treatments tested in this trial

  • Whole Grain Intervention then fruits and vegetables

    Other intervention

    TREATMENT 1: Participants will eat whole grains that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when they eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual. TREATMENT 2: Participants will eat fruits and vegetables that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when participants eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual.

  • Fruit and Vegetable Intervention and then whole grains

    Other intervention

    TREATMENT 1: Participants will eat fruits and vegetables that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when participants eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual. TREATMENT 2: Participants will eat whole grains that add up to the required daily fiber needs. Investigators will provide participants with these products. Participants will follow this intervention for a set period of time. The beginning of the intervention will include a ramp up phase when they eat half of the daily fiber needs to prevent any gastrointestinal distress from suddenly consuming a higher fiber diet than usual.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Experimental: Group A: Whole grains then fruits and vegetablesExperimental treatment 1 intervention
Group B: Experimental: Group B: Fruits and vegetables then whole grainsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Body weight changes

For each intervention (whole grains \& fruits and vegetables), investigators will measure change in body weight in kg = Post-intervention minus Pre-intervention

Time frame
3-4 weeks
2

Body fat percentage changes

For each intervention (whole grains \& fruits and vegetables), investigators will measure change in fat percentage = Post-intervention minus Pre-intervention

Time frame
3-4 weeks

Secondary outcomes

1

Gut microbiome measured by 16S rRNA gene sequencing

For each intervention (whole grains \& fruits and vegetables), investigators will calculate changes in relative abundance (proportion) of each gut bacterium from Pre-intervention to Post-intervention.

Time frame
3-4 weeks
2

Fecal short-chain fatty acid concentrations (SCFAs)

For each intervention (whole grains \& fruits and vegetables), investigators will measure change in SCFA concentrations = Post-intervention minus Pre-intervention. We will report the SCFAs acetate, butyrate, and propionate.

Time frame
3-4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cornell University

Lead sponsor

Source ClinicalTrials.gov
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