Sunfiber and the Microbiota



Status:Recruiting
Healthy:No
Age Range:20 - 49
Updated:10/31/2018
Start Date:November 2018
End Date:September 14, 2019
Contact:Rylee Ahnen, MS
Email:ahnen002@umn.edu
Phone:612-625-5264

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

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.

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).
We found this trial at
1
site
Saint Paul, Minnesota 55108
Principal Investigator: Joanne Slavin
Phone: 612-624-7234
?
mi
from
Saint Paul, MN
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