Sunfiber and the Microbiota

Not Applicable

Completed

• Conditions: Diet Modification
• Interventions: Dietary Supplement: Low fiber; Dietary Supplement: Placebo; Dietary Supplement: High fiber

• Registration Number: NCT03722862
• Lead Sponsor: University of Minnesota

Brief Summary

The aim of this study is to look at the effect Sunfiber has on the gut microbiota.

Detailed Description

This is a randomized, double-blind, placebo-controlled crossover study with a 2 week washout period. Healthy volunteers will receive placebo, 4 grams, or 8 grams of Sunfiber in addition to their regular diet. Fecal samples will be collected for measurement of bowl function, including the gut microbiota.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Study Start: 2019-04-05
• Primary Completion: 2019-08-31
• Study Completion: 2019-09-14
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

• History of a gastrointestinal disorder
• Lactose intolerant
• High fiber consumer (≥15 g per day)
• Use of pre-and probiotics in the past 90 days
• High protein consumer (i.e. vegetarians or those who follow diets high in protein such as paleo)
• History of psychological illness or conditions that may interfere with subjects ability to understand study directions
• Use of antibiotics or signs of active systemic infection in the last 6 months. Subjects who are on hypo/hypercaloric diet aiming for weight loss or weight gain
• History or presence of cancer in the prior 2 years (except for non-melanoma skin cancer).

Currently pregnant, lactating or planning to be pregnant during the study period

• Regular use of dietary supplements (ex: fish oil, riboflavin, etc.), 90 days prior to study inclusion
• Exposure to any non-registered drug product within the last 30 days prior to screening visit
• History of or strong potential for alcohol or substance abuse (within 12 months of screening visit). Alcohol abuse is defined as >60g (men)/40g (women) pure alcohol per day (1.5 L/ 1 l beer resp. 0.75l/0.5l wine).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low fiber	Low fiber	Healthy volunteers will be randomized to receive 3 grams of Sunfiber.
Control Arm	Placebo	Healthy volunteers will continue normal healthy diet with a placebo.
High fiber	High fiber	Healthy volunteers will be randomized to receive 6 grams of Sunfiber.

Primary Outcome Measures

Name	Time	Method
Analysis of Microbiota	Day 10	Bacterial phyla, genera, and species of bacteria will be detected using real tijme PCR. All abundances will be calculated and presented as relative levels (relative to the total amount of eubacteriausing a universal eubacteria prijer set)

Secondary Outcome Measures

Name	Time	Method
salivary cortisol	Day 10	Salivary cortisol will be measured using a competitive immunoassay. 25 ul of saliva will be used in each replicate and results will be compared to a standard curve and calculated as ug/dl.

Trial Locations

Locations (1)

Department of Food Science and Nutrition; 🇺🇸 Saint Paul, Minnesota, United States