Assessing the Dose Response of a Lead Fiber Snack Prototype
Public ClinicalTrials.gov record NCT04729816. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Assessing the Dose Response of a Lead Fiber Snack Prototype on the Gut Microbiome and Host Metabolome and Proteome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the gut microbiota of overweight and obese participants (BMI 25-35 kg/m2), while consuming a controlled diet that contains quantities of saturated fats in the upper tertile and quantities of fruits and vegetables in the lower tertile of consumption in the NHANES database (high saturated fat-low fruit and vegetable; HiSF-LoFV). Changes in the representation of bacterial genes involved in carbohydrate utilization in the microbiomes of participants will be correlated with changes in plasma biomarkers at the end of each escalating dose phase by comparing features of their pre- vs post-treatment plasma proteomes and metabolomes. Design: Participants will be asked to continue to consume their habitual diet (free diet phase) for 1 day prior to being provided with a HiSF-LoFV diet in the form of packed-out meals and snacks to consume for the following 62 days. Ten days after starting to consume the HiSF-LoFV diet, participants will supplement this diet with a fiber-blend containing snack (\~10g fiber/serving) once daily for a total of 14 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time and the remainder of the study. For the next 14 days, the diet will be supplemented with two of the same fiber-blend containing snacks per day, followed by 14 days in which the snacks will be consumed three times daily. Subsequently, a 'wash-out' phase of ten days in which the HiSF-LoFV diet is consumed without any of fiber snack supplementation will conclude the study. Stool, urine and blood will be sampled periodically throughout.
Study identification
- NCT ID
- NCT04729816
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 17 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 21, 2021
- Primary completion
- Nov 14, 2021
- Completion
- Nov 14, 2021
- Last update posted
- Dec 26, 2024
2021
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04729816, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 26, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04729816 live on ClinicalTrials.gov.