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Soy Fiber Improves Weight Loss and Lipid Profile

Primary Purpose

Obesity, Overweight, Weight Loss

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

biscuits supplemented with soy fiber

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

19 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

biscuits without soy fiber

biscuits supplemented with soy fiber

Arm Description

biscuits without soy fiber

biscuits supplemented with soy fiber

Outcomes

Primary Outcome Measures

weight loss

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

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

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

Body fat of participants in soy fiber group was lowered significantly at wk 12 than that of baseline.

Full Information

NCT ID

NCT01802840

First Posted

February 23, 2013

Last Updated

July 1, 2022

Sponsor

Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT01802840

Brief Title

Soy Fiber Improves Weight Loss and Lipid Profile

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight, Weight Loss

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

biscuits without soy fiber

Arm Type

Placebo Comparator

Arm Description

biscuits without soy fiber

Arm Title

biscuits supplemented with soy fiber

Arm Type

Experimental

Arm Description

biscuits supplemented with soy fiber

Intervention Type

Dietary Supplement

Intervention Name(s)

biscuits supplemented with soy fiber

Intervention 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).

Primary Outcome Measure Information:

Title

weight loss

Description

Body weight of participants in soy fiber group was decreased significantly over the study period compared with the baseline.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

serum levels of total cholesterol

Description

Serum levels of total cholesterol of participants in soy fiber group was decreased significantly over the study period compared with the baseline.

Time Frame

12 weeks

Title

serum levels of low density lipoprotein cholesterol

Description

Serum levels of low density lipoprotein cholesterol of participants in soy fiber group was decreased significantly over the study period compared with the baseline.

Time Frame

12 weeks

Title

body fat

Description

Body fat of participants in soy fiber group was lowered significantly at wk 12 than that of baseline.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Duo Li, Prof.

Organizational Affiliation

Zhejiang University

Official's Role

Study Director

Facility Information:

Facility Name

Zhejiang University

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310058

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

20102847

Citation

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.

Results Reference

background

PubMed Identifier

10546693

Citation

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.

Results Reference

background

PubMed Identifier

23881774

Citation

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.

Results Reference

derived

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Soy Fiber Improves Weight Loss and Lipid Profile

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