Soy Fiber Improves Weight Loss and Lipid Profile

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaojie Hu, Zhejiang University
ClinicalTrials.gov Identifier:
NCT01802840
First received: February 23, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Obesity
Overweight
Weight Loss
Dietary Supplement: biscuits supplemented with soy fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Soy Fiber Improves Weight Loss And Lipid Profile In Overweight And Obese Adults: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • weight loss [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body weight of participants in soy fiber group was decreased significantly over the study period compared with the baseline.


Secondary Outcome Measures:
  • serum levels of total cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Serum levels of total cholesterol of participants in soy fiber group was decreased significantly over the study period compared with the baseline.

  • serum levels of low density lipoprotein cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Serum levels of low density lipoprotein cholesterol of participants in soy fiber group was decreased significantly over the study period compared with the baseline.

  • body fat [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Body fat of participants in soy fiber group was lowered significantly at wk 12 than that of baseline.


Enrollment: 39
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: biscuits without soy fiber
biscuits without soy fiber
Experimental: biscuits supplemented with soy fiber
biscuits supplemented with soy fiber
Dietary Supplement: 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).

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.

  Eligibility

Ages Eligible for Study:   19 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802840

Locations
China, Zhejiang
Zhejiang University
Hangzhou, Zhejiang, China, 310058
Sponsors and Collaborators
Zhejiang University
Investigators
Study Director: Duo Li, Prof. Zhejiang University
  More Information