Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

Conditions
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Insulin Resistance

Intervention / Treatment
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* Other: Sugarcane bagasse
* Other: Non-caloric, non-fermentable fiber
* Other: Minimal fiber


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugarcane bagasse<br>10 subjects will consume food (brownies and cookies) made with 13 g of sugarcane bagasse everyday for 4 weeks | Other: Sugarcane bagasse<br>* 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)<br>|
| Active Comparator: Non-caloric, non-fermentable fiber<br>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<br>* 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)<br>|
| Placebo Comparator: Minimal fiber<br>10 subjects will consume food (brownies and cookies) made with 4 g of dietary fiber everyday for 4 weeks | Other: Minimal fiber<br>* One brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugarcane bagasse, glucose tolerance, insulin resistance