Effect of Oat Bran on Bowel Function and Appetite

Gastrointestinal Disorder, Functional Clinical Trial

— OATGUT  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03014141
• Other study ID #: 2015-12-10-OAT
• Status: Withdrawn
• Phase: N/A
• Start date: June 2018
• Est. completion date: March 2019

Study information

• Verified date: August 2018
• Source: DSM Nutritional Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• Gastrointestinal Disorder, Functional

Intervention

Other:
• Oat bran (Oatwell 28)
11 g oat bran containing 3.1 gram oat beta-glucan
• Maltodextrin
11 g of Maltodextrin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Stool frequency	using a bowel movement diary	2 weeks and 4 weeks
Secondary	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
Secondary	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
Secondary	Bristol Stool Score	using Bristol Stool Chart	2 weeks and 4 weeks
Secondary	Fecal pH		2 weeks and 4 weeks
Secondary	Subjective measures of bowel comfort	Gastrointestinal Quality of life questionnaires (GIQLI)	2 weeks and 4 weeks
Secondary	Gut microbiota	Using 16S ribosomal RNA sequencing techniques	2 weeks and 4 weeks
Secondary	Fecal short chain fatty acids	Using gas chromatography	2 weeks and 4 weeks
Secondary	Fecal total bile acids		2 weeks and 4 weeks
Secondary	Fecal enzymes	fecal beta-glucoronidase	2 weeks and 4 weeks
Secondary	Fecal ammonia		2 weeks and 4 weeks
Secondary	Intestinal gas production	using breath hydrogen production	2 weeks and 4 weeks
Secondary	Appetite	Appetite will be measured via visual analogue score (VAS)	2 weeks and 4 weeks
Secondary	Ad libitum energy intake	Ad libitum energy intake is measured by serving the subject an excess of food	2 weeks and 4 weeks