Soy Fiber Improves Weight Loss and Lipid Profile
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Mar 2012
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 23, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedJuly 7, 2022
July 1, 2022
3 months
February 23, 2013
July 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
weight loss
Body weight of participants in soy fiber group was decreased significantly over the study period compared with the baseline.
12 weeks
Secondary Outcomes (3)
serum levels of total cholesterol
12 weeks
serum levels of low density lipoprotein cholesterol
12 weeks
body fat
12 weeks
Study Arms (2)
biscuits without soy fiber
PLACEBO COMPARATORbiscuits without soy fiber
biscuits supplemented with soy fiber
EXPERIMENTALbiscuits supplemented with soy fiber
Interventions
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).
Eligibility Criteria
You may qualify if:
- BMI of 23-35 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhejiang University
Hangzhou, Zhejiang, 310058, China
Related Publications (3)
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.
PMID: 20102847BACKGROUNDLudwig 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.
PMID: 10546693BACKGROUNDHu 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.
PMID: 23881774DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Duo Li, Prof.
Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Msd
Study Record Dates
First Submitted
February 23, 2013
First Posted
March 1, 2013
Study Start
March 1, 2012
Primary Completion
June 1, 2012
Study Completion
July 1, 2012
Last Updated
July 7, 2022
Record last verified: 2022-07