Sunfiber and the Microbiota

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

Study Overview

• Status: Completed
• Conditions: Diet Modification
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Low fiber; Dietary supplement: High fiber

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55108
      • Department of Food Science and Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Healthy male or female between the ages of 20-49 years
• Subject has a body mass index of ≥18.5 and ≤30 kg/m2 at screening visit.
• Subject is willing to stick to their normal habitual diet excluding the consumption of any unusual high energy-rich or fat-rich meals or prolonged fasting, etc. through the study period.
• Subject is willing to maintain their habitual physical activity patterns throughout the study period.
• Subject has been weight stable within the last 6 months.
• Subject has no health conditions that would prevent him or her from fulfilling the study requirements as judged by the investigator on the basis of medical history and routine laboratory test results.
• Low fiber consumer (≤14 g per day)
• Subject is willing to follow study procedures and dietary restrictions (ex: stick to habitual diet, refrain from consuming alcohol 24 hours prior to test days).
• Subject understands study procedures and signs forms providing informed consent to participate in the study.

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Arm; Healthy volunteers will continue normal healthy diet with a placebo.	Dietary supplement: Placebo; Participants will receive the placebo/dextrose.
Experimental: Low fiber; Healthy volunteers will be randomized to receive 3 grams of Sunfiber.	Dietary supplement: Low fiber; Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 3 gram doses
Experimental: High fiber; Healthy volunteers will be randomized to receive 6 grams of Sunfiber.	Dietary supplement: High fiber; Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 6 gram doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of Microbiota	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)	Day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary cortisol	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.	Day 10

Collaborators and Investigators

• Sponsor: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): September 14, 2019

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: STUDY99994204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No