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Clinical Trials/NCT01802840
NCT01802840CompletedNot Applicable

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

Zhejiang University1 site in 1 country39 target enrollmentStarted: March 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
39
Locations
1
Primary Endpoint
weight loss

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 39 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • serum levels of low density lipoprotein cholesterol(12 weeks)
  • body fat(12 weeks)
  • serum levels of total cholesterol(12 weeks)

Investigators

Sponsor
Zhejiang University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiaojie Hu

Msd

Zhejiang University

Study Sites (1)

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