Effect of Oat Bran on Bowel Function and Appetite (OATGUT)

The Effect of Oat Bran on Bowel Function and Appetite. A Randomized, Double-blind, Placebo-controlled, Cross-over Intervention Study in Healthy Humans.

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.

Study Overview

• Status: Withdrawn
• Conditions: Gastrointestinal Disorder, Functional
• Intervention / Treatment: Other: Oat bran (Oatwell 28); Other: Maltodextrin

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oat bran (Oatwell 28); A beverage containing 11 gram (3 gram of oat beta-glucan) of Oat bran (Oatwell 28) will be consumed before breakfast	Other: Oat bran (Oatwell 28); 11 g oat bran containing 3.1 gram oat beta-glucan; Other Names: Oat bran oat beta-glucan
PLACEBO_COMPARATOR: Maltodextrin; A beverage containing 11 gram of maltodextrin will be consumed before breakfast.	Other: Maltodextrin; 11 g of Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole gut transit time	Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole gut transit time	Whole gut transit time is the time required for the passage of 80% of radio-opaque markers (ROM) which are detected by x-ray in the fecal samples collected over the next 5 days after swallowing the ROM.	2 weeks
Stool frequency	using a bowel movement diary	2 weeks and 4 weeks
Fecal output	Fecal out is the weight of the fecal samples collected over the 5 days preceding the 2 week and 4 week time point	2 weeks and 4 weeks
Percent fecal moisture	Fecal moisture is determined by freeze drying fecal samples and calculating the percent moisture in the fecal sample	2 weeks and 4 weeks
Bristol Stool Score	using Bristol Stool Chart	2 weeks and 4 weeks
Fecal pH		2 weeks and 4 weeks
Subjective measures of bowel comfort	Gastrointestinal Quality of life questionnaires (GIQLI)	2 weeks and 4 weeks
Gut microbiota	Using 16S ribosomal RNA sequencing techniques	2 weeks and 4 weeks
Fecal short chain fatty acids	Using gas chromatography	2 weeks and 4 weeks
Fecal total bile acids		2 weeks and 4 weeks
Fecal enzymes	fecal beta-glucoronidase	2 weeks and 4 weeks
Fecal ammonia		2 weeks and 4 weeks
Intestinal gas production	using breath hydrogen production	2 weeks and 4 weeks
Appetite	Appetite will be measured via visual analogue score (VAS)	2 weeks and 4 weeks
Ad libitum energy intake	Ad libitum energy intake is measured by serving the subject an excess of food	2 weeks and 4 weeks

Collaborators and Investigators

• Sponsor: DSM Nutritional Products, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): March 1, 2019

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (ESTIMATE): January 9, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 2015-12-10-OAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No