Insulin Resistance
Conditions
Keywords
Sugarcane bagasse, glucose tolerance, insulin resistance
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.
Interventions
OTHERSugarcane 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)
OTHERNon-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)
OTHERMinimal fiber
One brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day)
Sponsors
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed