Sunfiber and the Microbiota

NCT03722862 | Completed

• 1 other identifier: STUDY99994204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diet Modification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• salivary cortisol

  Day 10

Study Arms (3)

Control Arm

PLACEBO COMPARATOR

Healthy volunteers will continue normal healthy diet with a placebo.

Dietary Supplement: Placebo

Low fiber

EXPERIMENTAL

Healthy volunteers will be randomized to receive 3 grams of Sunfiber.

Dietary Supplement: Low fiber

High fiber

EXPERIMENTAL

Healthy volunteers will be randomized to receive 6 grams of Sunfiber.

Dietary Supplement: High fiber

Interventions

Low fiber DIETARY_SUPPLEMENT

Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 3 gram doses

Low fiber

Placebo DIETARY_SUPPLEMENT

Participants will receive the placebo/dextrose.

Control Arm

High fiber DIETARY_SUPPLEMENT

Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 6 gram doses

High fiber

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Department of Food Science and Nutrition

Saint Paul, Minnesota, 55108, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: fiber is provided in pouches; coded to treatment
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 arm crossover, randomized

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: October 29, 2018
• Study Start: April 5, 2019
• Primary Completion: August 31, 2019
• Study Completion: September 14, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)