Effect of Oat Bran on Bowel Function and Appetite
- Conditions
- Gastrointestinal Disorder, Functional
- Interventions
- Other: MaltodextrinOther: Oat bran (Oatwell 28)
- Registration Number
- NCT03014141
- Lead Sponsor
- DSM Nutritional Products, Inc.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Maltodextrin Maltodextrin A beverage containing 11 gram of maltodextrin will be consumed before breakfast. Oat bran (Oatwell 28) 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
- Primary Outcome Measures
Name Time Method Whole gut transit time 4 weeks 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.
- Secondary Outcome Measures
Name Time Method Fecal short chain fatty acids 2 weeks and 4 weeks Using gas chromatography
Fecal total bile acids 2 weeks and 4 weeks Fecal enzymes 2 weeks and 4 weeks fecal beta-glucoronidase
Fecal ammonia 2 weeks and 4 weeks Stool frequency 2 weeks and 4 weeks using a bowel movement diary
Fecal output 2 weeks and 4 weeks Fecal out is the weight of the fecal samples collected over the 5 days preceding the 2 week and 4 week time point
Whole gut transit time 2 weeks 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.
Bristol Stool Score 2 weeks and 4 weeks using Bristol Stool Chart
Fecal pH 2 weeks and 4 weeks Subjective measures of bowel comfort 2 weeks and 4 weeks Gastrointestinal Quality of life questionnaires (GIQLI)
Gut microbiota 2 weeks and 4 weeks Using 16S ribosomal RNA sequencing techniques
Percent fecal moisture 2 weeks and 4 weeks Fecal moisture is determined by freeze drying fecal samples and calculating the percent moisture in the fecal sample
Intestinal gas production 2 weeks and 4 weeks using breath hydrogen production
Appetite 2 weeks and 4 weeks Appetite will be measured via visual analogue score (VAS)
Ad libitum energy intake 2 weeks and 4 weeks Ad libitum energy intake is measured by serving the subject an excess of food