Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

NCT ID: NCT01830686

Last Updated: 2016-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

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.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sugarcane bagasse

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

Group Type EXPERIMENTAL

Sugarcane bagasse

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Non-caloric, non-fermentable fiber

Intervention Type OTHER

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

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

Group Type PLACEBO_COMPARATOR

Minimal fiber

Intervention Type OTHER

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

Interventions

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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)

Intervention Type OTHER

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)

Intervention Type OTHER

Minimal fiber

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pennington Biomedical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Daniel Hsia

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Hsia, MD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

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Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

Other Identifiers

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PBRC 13005

Identifier Type: -

Identifier Source: org_study_id

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