BROWNIE: Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

Sponsor

Pennington Biomedical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT01830686

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

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 Design

Study Type:

Interventional

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 :

Apr 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance [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

The effect of sugarcane bagasse on body weight/composition [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daniel Hsia, Principal Investigator, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT01830686

Other Study ID Numbers:

PBRC 13005

First Posted:

Apr 12, 2013

Last Update Posted:

Feb 3, 2016

Last Verified:

Feb 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Daniel Hsia, Principal Investigator, Pennington Biomedical Research Center

Sugarcane bagasse, glucose tolerance, insulin resistance

Additional relevant MeSH terms:

Insulin Resistance

Study Results

No Results Posted as of Feb 3, 2016