Clinical trial NCT03722862: Sunfiber and the Microbiota
Official title: Sunfiber and the Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 3 arm crossover, randomized
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Analysis of Microbiota
timeFrame: Day 10
Secondary outcomes:
measure: salivary cortisol
timeFrame: Day 10
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Department of Food Science and Nutrition
state: Minnesota
Study officials:
References: