Soy Fiber Improves Weight Loss and Lipid Profile

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802840
• Other study ID #: 12-01
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2022
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight
• Weight Loss

Intervention

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).

Locations

Country	Name	City	State
China	Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	Body weight of participants in soy fiber group was decreased significantly over the study period compared with the baseline.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	body fat	Body fat of participants in soy fiber group was lowered significantly at wk 12 than that of baseline.	12 weeks