Metabolic Effects of Short Term Sugarcane Bagasse Supplementation
BROWNIE
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 10, 2013
CompletedFirst Posted
Study publicly available on registry
April 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 3, 2016
February 1, 2016
9 months
April 10, 2013
February 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance
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.
4 weeks
Secondary Outcomes (1)
The effect of sugarcane bagasse on body weight/composition
4 weeks
Other Outcomes (1)
The effect of sugarcane bagasse on incretin profiles as a mechanism to explain its metabolic effects
4 Weeks
Study Arms (3)
Sugarcane bagasse
EXPERIMENTAL10 subjects will consume food (brownies and cookies) made with 13 g of sugarcane bagasse everyday for 4 weeks
Non-caloric, non-fermentable fiber
ACTIVE COMPARATOR10 subjects will consume food (brownies and cookies) made with 13 g of non caloric, non-fermentable fiber everyday for 4 weeks
Minimal fiber
PLACEBO COMPARATOR10 subjects will consume food (brownies and cookies) made with 4 g of dietary fiber everyday for 4 weeks
Interventions
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)
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)
One brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Hsia, MD
Pennington Biomedical Research Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 10, 2013
First Posted
April 12, 2013
Study Start
April 1, 2013
Primary Completion
January 1, 2014
Study Completion
December 1, 2014
Last Updated
February 3, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share