Soy Fiber Improves Weight Loss and Lipid Profile

NCT ID: NCT01802840

Last Updated: 2022-07-07

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-07-31

Brief Summary

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The aim of this study is to examine the effects of soy fiber on body weight, body composition and blood lipids in overweight and obese participants.

Detailed Description

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Thirty nine overweight and obese college adults (19-39 y of age) were randomly assigned to consume control biscuits or biscuits supplemented with soy fiber for 12 wk (approximately 100g/d). Information on body weight, body mass index, waist/hip circumference, blood pressure as well as measures of lipoprotein, glucose concentrations, and HbA1c was obtained at baseline, 8 and 12 wk after intervention. Body composition was also assessed at baseline and wk 12, respectively.

Conditions

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Obesity Overweight Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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biscuits without soy fiber

biscuits without soy fiber

Group Type PLACEBO_COMPARATOR

biscuits supplemented with soy fiber

Intervention Type DIETARY_SUPPLEMENT

Thirty nine overweight and obese college adults (19-39 y of age) were randomly assigned to consume control biscuits or biscuits supplemented with soy fiber for 12 wk (approximately 100g/d).

biscuits supplemented with soy fiber

biscuits supplemented with soy fiber

Group Type EXPERIMENTAL

biscuits supplemented with soy fiber

Intervention Type DIETARY_SUPPLEMENT

Thirty nine overweight and obese college adults (19-39 y of age) were randomly assigned to consume control biscuits or biscuits supplemented with soy fiber for 12 wk (approximately 100g/d).

Interventions

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biscuits supplemented with soy fiber

Thirty nine overweight and obese college adults (19-39 y of age) were randomly assigned to consume control biscuits or biscuits supplemented with soy fiber for 12 wk (approximately 100g/d).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI of 23-35 kg/m2

Exclusion Criteria

* Subjects taking any drugs, botanicals or nutraceutical known to influence body weight or blood pressure
* significant history of eating disorders
* strenuous exercise to lose weight
* lipid-lowering medication
* use of steroids and other agents that may influence lipid metabolism
* hyperlipidemia
* hyperglycemia
* diabetes mellitus
* cardiovascular disease
* major systemic diseases
* gastrointestinal problems
* liver and renal failure
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Xiaojie Hu

Msd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Duo Li, Prof.

Role: STUDY_DIRECTOR

Zhejiang University

Locations

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Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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Maki KC, Beiseigel JM, Jonnalagadda SS, Gugger CK, Reeves MS, Farmer MV, Kaden VN, Rains TM. Whole-grain ready-to-eat oat cereal, as part of a dietary program for weight loss, reduces low-density lipoprotein cholesterol in adults with overweight and obesity more than a dietary program including low-fiber control foods. J Am Diet Assoc. 2010 Feb;110(2):205-14. doi: 10.1016/j.jada.2009.10.037.

Reference Type BACKGROUND
PMID: 20102847 (View on PubMed)

Ludwig DS, Pereira MA, Kroenke CH, Hilner JE, Van Horn L, Slattery ML, Jacobs DR Jr. Dietary fiber, weight gain, and cardiovascular disease risk factors in young adults. JAMA. 1999 Oct 27;282(16):1539-46. doi: 10.1001/jama.282.16.1539.

Reference Type BACKGROUND
PMID: 10546693 (View on PubMed)

Hu X, Gao J, Zhang Q, Fu Y, Li K, Zhu S, Li D. Soy fiber improves weight loss and lipid profile in overweight and obese adults: a randomized controlled trial. Mol Nutr Food Res. 2013 Dec;57(12):2147-54. doi: 10.1002/mnfr.201300159. Epub 2013 Jul 23.

Reference Type DERIVED
PMID: 23881774 (View on PubMed)

Other Identifiers

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12-01

Identifier Type: -

Identifier Source: org_study_id

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