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Metabolic Effects of Short Term Sugarcane Bagasse Supplementation (BROWNIE)

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ClinicalTrials.gov Identifier: NCT01830686
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Daniel Hsia, Pennington Biomedical Research Center

Brief Summary:
The purpose of this study is to help understand the benefits of eating food supplemented with fiber in the form of sugarcane bagasse (the leftover fiber after cane juice is extracted) on glucose metabolism and body weight.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: Sugarcane bagasse Other: Non-caloric, non-fermentable fiber Other: Minimal fiber Not Applicable

Detailed Description:
The investigators will employ a double-blind randomized controlled study design with 3 arms such that obese, insulin resistant adults will be randomly selected to receive food made with 1) sugarcane bagasse, 2) non-caloric, non-fermentable fiber, or 3) a similar product with minimal fiber for 4 weeks. The intervention will be in the form of brownies and cookies and will look and taste nearly identical to each other. Caloric value will be constant with all three delivery systems. Subjects will have blood testing and body composition analysis before and after the intervention.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Metabolic Effects of Short Term Sugarcane Bagasse Supplementation
Study Start Date : April 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Sugarcane bagasse
10 subjects will consume food (brownies and cookies) made with 13 g of sugarcane bagasse everyday for 4 weeks
Other: Sugarcane bagasse
One brownie containing 10 g of sugarcane bagasse and 2 cookies containing 3 g of sugarcane bagasse (total of 13 g of sugarcane bagasse per day)

Active Comparator: Non-caloric, non-fermentable fiber
10 subjects will consume food (brownies and cookies) made with 13 g of non caloric, non-fermentable fiber everyday for 4 weeks
Other: Non-caloric, non-fermentable fiber
One brownie containing 10 g of fiber and 2 cookies containing 3 g of fiber (total of 13 g of non-caloric, non-fermentable fiber per day)

Placebo Comparator: Minimal fiber
10 subjects will consume food (brownies and cookies) made with 4 g of dietary fiber everyday for 4 weeks
Other: Minimal fiber
One brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day)




Primary Outcome Measures :
  1. The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance [ Time Frame: 4 weeks ]
    Participants will be randomly selected to eat food supplemented with either 1) sugarcane bagasse, 2) another type of fiber of equal weight, or 3) minimal fiber. At baseline each eligible subject will have a 3 hour oral glucose tolerance test. Subjects will consume one brownie and two cookies a day for four weeks. At the end of four weeks, the blood tests conducted at baseline will be repeated.


Secondary Outcome Measures :
  1. The effect of sugarcane bagasse on body weight/composition [ Time Frame: 4 weeks ]
    At baseline and weekly till the end of the study, weight will be measured. In addition body composition via DXA will be measured at baseline and at the end of the study.


Other Outcome Measures:
  1. The effect of sugarcane bagasse on incretin profiles as a mechanism to explain its metabolic effects [ Time Frame: 4 Weeks ]
    At baseline and at the end of the study, glucagon-like peptide-1 and ghrelin levels will be measured.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females age 18-50 years
  • Body Mass Index ≥ 30 kg/m2 (a ratio of weight to height)
  • Fasting insulin level >5 µIU/mL, as determined by tests performed during screening

Exclusion Criteria:

  • Women who are pregnant
  • Past medical history of diabetes
  • History of intestinal surgery such as removal of bowel
  • History of problems with absorbing food such as celiac disease, inflammatory bowel disease, malabsorption syndrome
  • Taking chronic medications for any medical conditions such as diabetes, hypertension, cholesterol, thyroid hormone, etc.
  • Any food allergies

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): NCT01830686


Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Daniel Hsia, MD Pennington Biomedical Research Center

Responsible Party: Daniel Hsia, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01830686     History of Changes
Other Study ID Numbers: PBRC 13005
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Daniel Hsia, Pennington Biomedical Research Center:
Sugarcane bagasse, glucose tolerance, insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases