ObesityNCT01802840
Soy Fiber Improves Weight Loss and Lipid Profile
A study testing biscuits supplemented with soy fiber in people with Obesity and Overweight, run by Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 19 to 39 years
- Conditions the study is for
- Obesity, Overweight, Weight Loss
- What is being tested?
- biscuits supplemented with soy fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI of 23-35 kg/m2
Who cannot join
- 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
Show all 12Show fewer
- hyperglycemia
- diabetes mellitus
- cardiovascular disease
- major systemic diseases
- gastrointestinal problems
- liver and renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soy Fiber Improves Weight Loss And Lipid Profile In Overweight And Obese Adults: A Randomized Controlled Trial
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.
- Conditions
- Obesity, Overweight, Weight Loss
- Being tested
- biscuits supplemented with soy fiber
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biscuits supplemented with soy fiberDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| biscuits without soy fiber | Placebo comparator | biscuits without soy fiber Receives: Dietary Supplement: biscuits supplemented with soy fiber |
| biscuits supplemented with soy fiber | Experimental | biscuits supplemented with soy fiber Receives: Dietary Supplement: biscuits supplemented with soy fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Body weight of participants in soy fiber group was decreased significantly over the study period compared with the baseline.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
body fat
Body fat of participants in soy fiber group was lowered significantly at wk 12 than that of baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMar 2012
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaojie Hu, Zhejiang University
- Investigators
- Duo Li, Prof., Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802840
- Sponsor's protocol ID
- 12-01
- Status last verified
- Jul 2022
- First submitted
- 23 Feb 2013
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
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 20102847Ludwig 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 10546693Hu 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy Fiber Improves Weight Loss And Lipid Profile In Overweight And Obese Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01802840
- Acronym / sponsor ID
- 12-01
- Conditions
- Obesity, Overweight, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biscuits without soy fiber | Placebo comparator | Dietary Supplement: biscuits supplemented with soy fiberbiscuits without soy fiber |
| biscuits supplemented with soy fiber | Experimental | Dietary Supplement: biscuits supplemented with soy fiberbiscuits supplemented with soy fiber |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI of 23-35 kg/m2
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biscuits supplemented with soy fiberThirty 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). | Dietary supplement | biscuits supplemented with soy fiber, biscuits without soy fiber |
Primary outcome
weight loss
Time frame: 12 weeks
Body weight of participants in soy fiber group was decreased significantly over the study period compared with the baseline.
3 secondary outcomes
serum levels of total cholesterol
Time frame: 12 weeks
serum levels of low density lipoprotein cholesterol
Time frame: 12 weeks
body fat
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Background: PubMed 20102847Maki 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.
- Background: PubMed 10546693Ludwig 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.
- Derived from this study: PubMed 23881774Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duo Li, Prof. study director
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biscuits supplemented with soy fiber in people with Obesity and Overweight, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01802840, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.