Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

Not Applicable

Completed

• Conditions: Insulin Resistance
• Interventions: Other: Non-caloric, non-fermentable fiber; Other: Sugarcane bagasse; Other: Minimal fiber

• Registration Number: NCT01830686
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-12
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-caloric, non-fermentable fiber	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
Sugarcane bagasse	Sugarcane bagasse	10 subjects will consume food (brownies and cookies) made with 13 g of sugarcane bagasse everyday for 4 weeks
Minimal fiber	Minimal fiber	10 subjects will consume food (brownies and cookies) made with 4 g of dietary fiber everyday for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States