Effect of Oat Bran on Bowel Function and Appetite

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastrointestinal Disorder, Functional

Intervention / Treatment
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* Other: Oat bran (Oatwell 28)
* Other: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oat bran (Oatwell 28)<br>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)<br>* 11 g oat bran containing 3.1 gram oat beta-glucan<br>* Other names: Oat bran oat beta-glucan;|
| Placebo Comparator: Maltodextrin<br>A beverage containing 11 gram of maltodextrin will be consumed before breakfast. | Other: Maltodextrin<br>* 11 g of Maltodextrin<br>|

What is the study measuring?
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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 |