Effect of Oat Bran on Bowel Function and Appetite

NCT03014141 | Withdrawn

• 1 other identifier: 2015-12-10-OAT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Disorder, Functional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Whole gut transit time

  2 weeks

• Stool frequency

  2 weeks and 4 weeks

• Fecal output

  2 weeks and 4 weeks

• Percent fecal moisture

  2 weeks and 4 weeks

• Bristol Stool Score

  2 weeks and 4 weeks

Study Arms (2)

Oat bran (Oatwell 28)

ACTIVE COMPARATOR

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)

Maltodextrin

PLACEBO COMPARATOR

A beverage containing 11 gram of maltodextrin will be consumed before breakfast.

Other: Maltodextrin

Interventions

Oat bran (Oatwell 28) OTHER

11 g oat bran containing 3.1 gram oat beta-glucan

Also known as: Oat bran oat beta-glucan

Oat bran (Oatwell 28)

Maltodextrin OTHER

11 g of Maltodextrin

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead

Related Publications (3)

• 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.

  PMID: 18926133 BACKGROUND

• 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.

  PMID: 20090313 BACKGROUND

• 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.

  PMID: 9734752 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Joanne Slavin, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 9, 2017
• Study Start: June 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share