Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 226 for:    Intestinal | maltodextrin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014141
Recruitment Status : Withdrawn (Study supply issues)
First Posted : January 9, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Disorder, Functional Other: Oat bran (Oatwell 28) Other: Maltodextrin Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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 Name: 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




Primary Outcome Measures :
  1. Whole gut transit time [ Time Frame: 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 :
  1. Whole gut transit time [ Time Frame: 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.

  2. Stool frequency [ Time Frame: 2 weeks and 4 weeks ]
    using a bowel movement diary

  3. Fecal output [ Time Frame: 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

  4. Percent fecal moisture [ Time Frame: 2 weeks and 4 weeks ]
    Fecal moisture is determined by freeze drying fecal samples and calculating the percent moisture in the fecal sample

  5. Bristol Stool Score [ Time Frame: 2 weeks and 4 weeks ]
    using Bristol Stool Chart

  6. Fecal pH [ Time Frame: 2 weeks and 4 weeks ]
  7. Subjective measures of bowel comfort [ Time Frame: 2 weeks and 4 weeks ]
    Gastrointestinal Quality of life questionnaires (GIQLI)

  8. Gut microbiota [ Time Frame: 2 weeks and 4 weeks ]
    Using 16S ribosomal RNA sequencing techniques

  9. Fecal short chain fatty acids [ Time Frame: 2 weeks and 4 weeks ]
    Using gas chromatography

  10. Fecal total bile acids [ Time Frame: 2 weeks and 4 weeks ]
  11. Fecal enzymes [ Time Frame: 2 weeks and 4 weeks ]
    fecal beta-glucoronidase

  12. Fecal ammonia [ Time Frame: 2 weeks and 4 weeks ]
  13. Intestinal gas production [ Time Frame: 2 weeks and 4 weeks ]
    using breath hydrogen production

  14. Appetite [ Time Frame: 2 weeks and 4 weeks ]
    Appetite will be measured via visual analogue score (VAS)

  15. Ad libitum energy intake [ Time Frame: 2 weeks and 4 weeks ]
    Ad libitum energy intake is measured by serving the subject an excess of food



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014141


Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Joanne Slavin, PhD University of Minnesota

Publications:
Layout table for additonal information
Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT03014141     History of Changes
Other Study ID Numbers: 2015-12-10-OAT
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Gastrointestinal Diseases
Digestive System Diseases