Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

Insulin Resistance Clinical Trial

— BROWNIE  

Official title:

Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830686
• Other study ID #: PBRC 13005
• Status: Completed
• Phase: N/A
• First received: April 10, 2013
• Last updated: February 1, 2016
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

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)
• 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)
• Minimal fiber
One brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day)

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No