Assessing the Dose Response of a Lead Fiber Snack Prototype

NCT ID: NCT04729816

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2021-11-15

Brief Summary

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.

Conditions

Microbiota; Gastrointestinal Microbiome

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dietary Intervention

All participants will stay weight stable while undergoing 5 phases of a dietary intervention that lasts 62 days.

Group Type: EXPERIMENTAL

Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food.

Intervention Type: OTHER

Phase 1: Participants will be provided with a high fat/low fiber diet in the form of packed out meals and snacks for 10 days in total (days 2-11 and days 54-63)

Phase 2: Participants will be provided with the high fat/low fiber diet, plus 1 daily fiber-blend snack serving from days 12-25

Phase 3: Participants will receive 2 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 26-39.

Phase 4: Participants will receive 3 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 40-53.

Phase 5: Participants will return to the unsupplemented high fat/low fiber diet for days 54-63

Interventions

Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food.

Phase 1: Participants will be provided with a high fat/low fiber diet in the form of packed out meals and snacks for 10 days in total (days 2-11 and days 54-63)

Phase 2: Participants will be provided with the high fat/low fiber diet, plus 1 daily fiber-blend snack serving from days 12-25

Phase 3: Participants will receive 2 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 26-39.

Phase 4: Participants will receive 3 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 40-53.

Phase 5: Participants will return to the unsupplemented high fat/low fiber diet for days 54-63

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI ≥25.0 and ≤35.0 kg/m2

Exclusion Criteria

• Previous bariatric surgery
• Significant organ system dysfunction (e.g. diabetes, severe pulmonary, kidney, liver, or -cardiovascular disease)
• Cancer or cancer that has been in remission for less than 5 years
• Major psychiatric illness
• Inflammatory gastrointestinal disease
• Pregnant or lactating women
• Use of medications that are known to affect the study outcome measures
• Use of medications or supplements known to affect composition of the gut microbiota within the last 30 days (e.g. antibiotics)
• Bowel movements less than 3 times per week
• Vegans, vegetarians, and those with allergies, aversions, or sensitivities to foods provided in the study
• Persons that are not able to grant voluntary informed consent
• Persons who are unable or unwilling to follow the study protocol or who the research team deems not an appropriate candidate for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

References

Patnode ML, Beller ZW, Han ND, Cheng J, Peters SL, Terrapon N, Henrissat B, Le Gall S, Saulnier L, Hayashi DK, Meynier A, Vinoy S, Giannone RJ, Hettich RL, Gordon JI. Interspecies Competition Impacts Targeted Manipulation of Human Gut Bacteria by Fiber-Derived Glycans. Cell. 2019 Sep 19;179(1):59-73.e13. doi: 10.1016/j.cell.2019.08.011.

Reference Type: BACKGROUND

PMID: 31539500 (View on PubMed)

Other Identifiers

202010046

Identifier Type: -

Identifier Source: org_study_id