Metabolic Effects of Short Term Sugarcane Bagasse Supplementation (BROWNIE)

Pennington Biomedical Research Center

Status: Completed

Conditions: Insulin Resistance

Treatments: Other: Non-caloric, non-fermentable fiber; Other: Sugarcane bagasse; Other: Minimal fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT01830686

PBRC 13005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 3 patient groups, including a placebo group

Sugarcane bagasse

Experimental group

Description:

10 subjects will consume food (brownies and cookies) made with 13 g of sugarcane bagasse everyday for 4 weeks

Treatment:

Other: Sugarcane bagasse

Non-caloric, non-fermentable fiber

Active Comparator group

Description:

10 subjects will consume food (brownies and cookies) made with 13 g of non caloric, non-fermentable fiber everyday for 4 weeks

Treatment:

Other: Non-caloric, non-fermentable fiber

Minimal fiber

Placebo Comparator group

Description:

10 subjects will consume food (brownies and cookies) made with 4 g of dietary fiber everyday for 4 weeks

Treatment:

Other: Minimal fiber