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CompletedNCT01802840Updated Jul 7, 2022

Soy Fiber Improves Weight Loss and Lipid Profile

An interventional study of biscuits supplemented with soy fiber in Obesity, Overweight and Weight Loss, sponsored by Zhejiang University. Completed at 1 site in China. Open to participants aged 19 Years to 39 Years. Per ClinicalTrials.gov, last updated 2022-07-07.

Sponsored by Zhejiang University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
19 Years to 39 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Overweight
  • Weight Loss
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 39 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • BMI of 23-35 kg/m2

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
39 participants (actual)

Study arms

  • Placebo comparator
    biscuits without soy fiber

    biscuits without soy fiber

    Dietary Supplement: biscuits supplemented with soy fiber

  • Experimental
    biscuits supplemented with soy fiber

    biscuits supplemented with soy fiber

    Dietary Supplement: biscuits supplemented with soy fiber

Interventions

  • Dietary supplementbiscuits 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).

06

What researchers measure

Primary outcomes

  1. weight loss

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

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. body fat

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Zhejiang University
    Hangzhou, Zhejiang 310058, China
08

References and documents

Publications

  • 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. PubMed 20102847 ↗
  • 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. PubMed 10546693 ↗
  • 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. PubMed 23881774 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01802840
Lead sponsor
Zhejiang University
Responsible party
Xiaojie Hu (Msd, Zhejiang University) — Principal investigator
First posted
Mar 1, 2013
Start date
Mar 2012
Primary completion
Jun 2012
Completion
Jul 2012
Last update
Jul 7, 2022

Study contacts

Duo Li, Prof.
study director · Zhejiang University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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