Metabolic Effects of Short Term Sugarcane Bagasse Supplementation (BROWNIE)

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance
• Intervention / Treatment: Other: Sugarcane bagasse; Other: Non-caloric, non-fermentable fiber; Other: Minimal fiber

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
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of sugarcane bagasse on body weight/composition	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.	4 weeks

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Daniel Hsia, MD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 10, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Estimate): February 3, 2016
• Last Update Submitted That Met QC Criteria: February 1, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Sugarcane bagasse, glucose tolerance, insulin resistance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: PBRC 13005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No