Clinical trial NCT03014141: Effect of Oat Bran on Bowel Function and Appetite
Official title: The Effect of Oat Bran on Bowel Function and Appetite. A Randomized, Double-blind, Placebo-controlled, Cross-over Intervention Study in Healthy Humans.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastrointestinal Disorder, Functional
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The consumption of oat bran fiber also has a significant bulking effect in humans. However, besides fecal bulk, dietary fiber can promote gut health in other ways. Therefore, the purpose of this study is to investigate the effects of oat bran (rich in oat beta-glucan) supplementation on bowel function and appetite.

Detailed description: The study is a randomized, double-blind, placebo-controlled crossover study it involves a total of 8 visits with a 14 day run-in period for total study duration of 84 days. A washout period of 2 weeks will occur in between the 2, 28 day treatment periods. The effects of an oat bran beverage for breakfast on bowel function will be tested after 2 week and 4 weeks of intake.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female between the ages of 18-60 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).

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).
* Allergy or sensitivity to oat bran or any meals or snacks provided
* Current smoker or use of tobacco products in the past 90 days
* Concurrent or recent participation (30 days) in a dietary intervention trial
* Anything in the judgment of the investigator would interfere with the subject's ability to comply with the study (protocol), which might confound the interpretation of the study results, or put the subject at undue risk.

Primary outcomes:
measure: Whole gut transit time
timeFrame: 4 weeks
Secondary outcomes:
measure: Whole gut transit time
timeFrame: 2 weeks
measure: Stool frequency
timeFrame: 2 weeks and 4 weeks
measure: Fecal output
timeFrame: 2 weeks and 4 weeks
measure: Percent fecal moisture
timeFrame: 2 weeks and 4 weeks
measure: Bristol Stool Score
timeFrame: 2 weeks and 4 weeks
measure: Fecal pH
timeFrame: 2 weeks and 4 weeks
measure: Subjective measures of bowel comfort
timeFrame: 2 weeks and 4 weeks
measure: Gut microbiota
timeFrame: 2 weeks and 4 weeks
measure: Fecal short chain fatty acids
timeFrame: 2 weeks and 4 weeks
measure: Fecal total bile acids
timeFrame: 2 weeks and 4 weeks
measure: Fecal enzymes
timeFrame: 2 weeks and 4 weeks
measure: Fecal ammonia
timeFrame: 2 weeks and 4 weeks
measure: Intestinal gas production
timeFrame: 2 weeks and 4 weeks
measure: Appetite
timeFrame: 2 weeks and 4 weeks
measure: Ad libitum energy intake
timeFrame: 2 weeks and 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Joanne Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grabitske HA, Slavin JL. Low-digestible carbohydrates in practice. J Am Diet Assoc. 2008 Oct;108(10):1677-81. doi: 10.1016/j.jada.2008.07.010.
citation: Stewart ML, Nikhanj SD, Timm DA, Thomas W, Slavin JL. Evaluation of the effect of four fibers on laxation, gastrointestinal tolerance and serum markers in healthy humans. Ann Nutr Metab. 2010;56(2):91-8. doi: 10.1159/000275962. Epub 2010 Jan 19.
citation: Chen HL, Haack VS, Janecky CW, Vollendorf NW, Marlett JA. Mechanisms by which wheat bran and oat bran increase stool weight in humans. Am J Clin Nutr. 1998 Sep;68(3):711-9. doi: 10.1093/ajcn/68.3.711.