Soy Fiber Improves Weight Loss and Lipid Profile

July 1, 2022 updated by: Xiaojie Hu, Zhejiang University

Soy Fiber Improves Weight Loss And Lipid Profile In Overweight And Obese Adults: A Randomized Controlled Trial

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310058
        • Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: biscuits without 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).
Experimental: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: 12 weeks
Body weight of participants in soy fiber group was decreased significantly over the study period compared with the baseline.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum levels of total cholesterol
Time Frame: 12 weeks
Serum levels of total cholesterol of participants in soy fiber group was decreased significantly over the study period compared with the baseline.
12 weeks
serum levels of low density lipoprotein cholesterol
Time Frame: 12 weeks
Serum levels of low density lipoprotein cholesterol of participants in soy fiber group was decreased significantly over the study period compared with the baseline.
12 weeks
body fat
Time Frame: 12 weeks
Body fat of participants in soy fiber group was lowered significantly at wk 12 than that of baseline.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Duo Li, Prof., Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 23, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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