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Metabolic Effects of Short Term Sugarcane Bagasse Supplementation

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StaatusValmis
Sponsorid
Pennington Biomedical Research Center

Märksõnad

Abstraktne

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.

Kirjeldus

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.

Kuupäevad

Viimati kinnitatud: 01/31/2016
Esmalt esitatud: 04/09/2013
Hinnanguline registreerumine on esitatud: 04/09/2013
Esmalt postitatud: 04/11/2013
Viimane värskendus on esitatud: 01/31/2016
Viimati värskendus postitatud: 02/02/2016
Õppe tegelik alguskuupäev: 03/31/2013
Eeldatav esmane lõpetamise kuupäev: 12/31/2013
Eeldatav uuringu lõpetamise kuupäev: 11/30/2014

Seisund või haigus

Insulin Resistance

Sekkumine / ravi

Other: Sugarcane bagasse

Other: Non-caloric, non-fermentable fiber

Other: Minimal fiber

Faas

-

Käerühmad

ArmSekkumine / ravi
Experimental: Sugarcane bagasse
10 subjects will consume food (brownies and cookies) made with 13 g of sugarcane bagasse everyday for 4 weeks
Other: 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)
Active Comparator: 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
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)
Placebo Comparator: Minimal fiber
10 subjects will consume food (brownies and cookies) made with 4 g of dietary fiber everyday for 4 weeks
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)

Abikõlblikkuse kriteeriumid

Õppimiseks sobivad vanused 18 Years To 18 Years
Uuringuks kõlblikud soodAll
Võtab vastu tervislikke vabatahtlikkeJah
Kriteeriumid

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

Tulemus

Esmased tulemusnäitajad

1. 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.

Sekundaarsed tulemusmõõdud

1. 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.

Muud tulemusmeetmed

1. 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.

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