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OpenTrials
Completed

NCT Number: NCT03722862

Sunfiber and the Microbiota

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

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Key information

Conditions

Age range

20 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food Science and Nutrition

Saint Paul, Minnesota, 55108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Low Fiber

Dietary Supplement

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

Placebo

Dietary Supplement

Participants will receive the placebo/dextrose.

High fiber

Dietary Supplement

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

Primary outcomes

  1. Analysis of Microbiota

    Time frame: 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 outcomes

  1. salivary cortisol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2018
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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