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Completed

NCT Number: NCT01830686

Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

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.

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugarcane bagasse

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

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

Other

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

Primary outcomes

  1. The benefit of sugarcane bagasse on glucose tolerance and insulin resistance in adults with established insulin resistance

    Time frame: 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 outcomes

  1. The effect of sugarcane bagasse on body weight/composition

    Time frame: 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 outcomes

  1. The effect of sugarcane bagasse on incretin profiles as a mechanism to explain its metabolic effects

    Time frame: 4 Weeks

    At baseline and at the end of the study, glucagon-like peptide-1 and ghrelin levels will be measured.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: BROWNIE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 12, 2013
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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