NCT01802840

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

February 23, 2013

Last Update Submit

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 COMPARATOR

biscuits without soy fiber

Dietary Supplement: biscuits supplemented with soy fiber

biscuits supplemented with soy fiber

EXPERIMENTAL

biscuits supplemented with soy fiber

Dietary Supplement: biscuits 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).

biscuits supplemented with soy fiberbiscuits without soy fiber

Eligibility Criteria

Age19 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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: 20102847BACKGROUND
  • 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.

    PMID: 10546693BACKGROUND
  • 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.

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Duo Li, Prof.

    Zhejiang University

    STUDY DIRECTOR

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

Locations