Central ObesityNCT02375113
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
A study testing soy supplementation in people with Central Obesity, run by The University of Texas at San Antonio at 1 site in United States.
Trial summary
This is a pilot study examining the effect of dietary supplements that contain soy products. The purpose of this study to find out if soy supplementation can help to reduce the storage of a certain kind of fat on the body, visceral fat. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Central Obesity
- What is being tested?
- soy supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 45 and 60
- experiencing irregular menses along with one or more other symptoms of menopause including: vaginal dryness, difficulty sleeping, hot flashes, mood changes, increased abdominal/belly fat, or with cessation of menstrual cycle for no more than three years
- having a BMI greater than 25
- Waist circumference greater than 88 cm
- having the ability to understand study procedures and to comply with them for the entire length of the study.
Who cannot join
- Have ever been diagnosed with cancer
- Have tumors in the reproductive system
- Allergies to soy or milk protein
- Have known metabolic disorders that may affect body weight and body composition (e.g., hypercortisolism and hypothyroidism, non-alcoholic fatty liver disease)
- Are receiving hormone replacement therapy or estrogen-like remedy
- Are taking medications (e.g., thyroid, cortisol/cortisone, ephedra, thermogenics, etc) within 30 days prior to the start of the study.
- Are emotional or uncontrolled eaters as measured by a brief screening tool Three-Factor Eating Questionnaire (TFEQ), i.e., 3 "yes" to the three emotional eating questions or 2 "yes" to the 2 uncontrolled eating questions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soy as an Innovative Dietary Component in Abdominal Obesity Management
This is a pilot study examining the effect of dietary supplements that contain soy products. The purpose of this study to find out if soy supplementation can help to reduce the storage of a certain kind of fat on the body, visceral fat. Visceral fat is fat found deep in the abdomen; it has the potential to increase the risk of certain health problems.
Read the detailed description
Obesity is a leading risk factor for many chronic diseases in the USA. Abdominal fat, specifically visceral fat is metabolically active and can be detrimental to health. Abdominal obesity is especially high in postmenopausal women (prevalence rates 50- 70%) in whom estrogen deficiency may lead to accumulation of excess visceral fat. Although estrogen replacement therapy is effective in preventing visceral fat accumulation, its adverse effects warrant a search for a safer phytochemical that exerts estrogenic properties. Soy, containing isoflavones (estrogen-like compounds), is a promising dietary component in reducing abdominal obesity in menopausal women. The favorable effects of isoflavones were already demonstrated in animal studies.The effects of soy compounds as a dietary component in preventing and reducing abdominal obesity and its associated metabolic abnormalities will be examined among menopausal Women. We will use quantitative magnetic resonance spectroscopy/imaging (qMRS/I) to determine dose and effects of soy supplementation for preventing and treating abdominal adiposity. The results from this study will shed light on the application of soy as a novel dietary approach in preventing and managing abdominal obesity among peri- and early menopausal women.
- Conditions
- Central Obesity
- Being tested
- soy supplementation
- Keywords
- Obesity prevention, Soy supplementation
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy supplementationDietary supplement
Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day Receives: Dietary Supplement: soy supplementation |
| Control | Placebo comparator | Placebo capsules + 25 gram whey protein / day Receives: Dietary Supplement: soy supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Fat (kg)
Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA)
Measured: Study endpoint (6 months post intervention)
Secondary outcomes (7)
BMI (kg/m^2)
Body Mass Index (BMI) was calculated using the equation of weight (kg) over height (m) squared (kg/m^2)
Measured: Study endpoint (6 months post intervention)
Blood Pressure (mmHg)
Subjects' resting systolic and diastolic blood pressure (SBP and DBP, mmHg) was measured with an electronic sphygmomanometer (Omron, USA).
Measured: Study endpoint (6 months post intervention)
Lipid Profile and Fasting Glucose
High-density lipoprotein (HDL) (mg/L) normal range > 40 mg/dL Low-density lipoprotein (LDL) (mg/L) normal range <100 mg/dL Triglyceride (TG) (mg/L) normal range <150 mg/dl Fasting glucose (mg/dl) normal range: <100 mg/dl C-Reactive Protein (mg/dl): <3 mg/dl in healthy individuals
Measured: Study endpoint (6 months post intervention)
Waist Circumference (cm)
Waist Circumference was measured midway between the iliac crest and bottom of the rib cage (cm)
Measured: Study endpoint (6 months post intervention)
Insulin Resistance
Insulin sensitivity index as measured by homeostasis model assessment-insulin resistance (HOMA-IR Index): Normal range 0.5-1.4
Measured: Study endpoint (6 months post intervention)
Inflammatory Cytokines IL-6 (ng/ml)
Inflammatory cytokines IL-6 (ng/ml): 75-80 ng/ml in healthy individuals
Measured: Study endpoint (6 months post intervention)
C-Reactive Protein (mg/L)
C-Reactive Protein (mg/L) <3 mg/L in healthy individuals
Measured: Study endpoint (6 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Meizi He, The University of Texas at San Antonio
- Investigators
- Meizi He, PhD, Principal investigator, University of Texas at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02375113
- Sponsor's protocol ID
- CRSGP 2012
- Status last verified
- May 2022
- First submitted
- 28 Feb 2013
- Last updated
- 10 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Umana CK, Wilmoth S, Pan M, Zhang JQ, Fogt DL, He M. Effects of Soy Supplementation on Abdominal Obesity and Metabolic Risks on Post-Menopausal Women: A Pilot Study. Austin Journal of Obesity & Metabolic Syndrome. (1): 1-6, 2017.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soy as an Innovative Dietary Component in Abdominal Obesity Management
- ClinicalTrials.gov ID
- NCT02375113
- Acronym / sponsor ID
- CRSGP 2012
- Conditions
- Central Obesity
- Keywords
- Obesity prevention, Soy supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas at San AntonioUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Posted 10 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study examining the effect of dietary supplements that contain soy products. The purpose of this study to find out if soy supplementation can help to reduce the storage of a certain kind of fat on the body, visceral fat. Visceral fat is fat found deep in the abdomen; it has the potential to increase the risk of certain health problems.
Detailed description
Obesity is a leading risk factor for many chronic diseases in the USA. Abdominal fat, specifically visceral fat is metabolically active and can be detrimental to health. Abdominal obesity is especially high in postmenopausal women (prevalence rates 50- 70%) in whom estrogen deficiency may lead to accumulation of excess visceral fat. Although estrogen replacement therapy is effective in preventing visceral fat accumulation, its adverse effects warrant a search for a safer phytochemical that exerts estrogenic properties. Soy, containing isoflavones (estrogen-like compounds), is a promising dietary component in reducing abdominal obesity in menopausal women. The favorable effects of isoflavones were already demonstrated in animal studies.The effects of soy compounds as a dietary component in preventing and reducing abdominal obesity and its associated metabolic abnormalities will be examined among menopausal Women. We will use quantitative magnetic resonance spectroscopy/imaging (qMRS/I) to determine dose and effects of soy supplementation for preventing and treating abdominal adiposity. The results from this study will shed light on the application of soy as a novel dietary approach in preventing and managing abdominal obesity among peri- and early menopausal women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: soy supplementationSoy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day |
| Control | Placebo comparator | Dietary Supplement: soy supplementationPlacebo capsules + 25 gram whey protein / day |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 45 and 60
- experiencing irregular menses along with one or more other symptoms of menopause including: vaginal dryness, difficulty sleeping, hot flashes, mood changes, increased abdominal/belly fat, or with cessation of menstrual cycle for no more than three years
- having a BMI greater than 25
- Waist circumference greater than 88 cm
- having the ability to understand study procedures and to comply with them for the entire length of the study.
Key exclusion criteria (7 listed)
- Have ever been diagnosed with cancer
- Have tumors in the reproductive system
- Allergies to soy or milk protein
- Have known metabolic disorders that may affect body weight and body composition (e.g., hypercortisolism and hypothyroidism, non-alcoholic fatty liver disease)
- Are receiving hormone replacement therapy or estrogen-like remedy
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 |
|---|---|---|
| soy supplementationIsoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months. Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone. | Dietary supplement | Control, Intervention |
Primary outcome
Body Fat (kg)
Time frame: Study endpoint (6 months post intervention)
Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA)
7 secondary outcomes
BMI (kg/m^2)
Time frame: Study endpoint (6 months post intervention)
Blood Pressure (mmHg)
Time frame: Study endpoint (6 months post intervention)
Lipid Profile and Fasting Glucose
Time frame: Study endpoint (6 months post intervention)
Waist Circumference (cm)
Time frame: Study endpoint (6 months post intervention)
Insulin Resistance
Time frame: Study endpoint (6 months post intervention)
Inflammatory Cytokines IL-6 (ng/ml)
Time frame: Study endpoint (6 months post intervention)
C-Reactive Protein (mg/L)
Time frame: Study endpoint (6 months post intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationUmana CK, Wilmoth S, Pan M, Zhang JQ, Fogt DL, He M. Effects of Soy Supplementation on Abdominal Obesity and Metabolic Risks on Post-Menopausal Women: A Pilot Study. Austin Journal of Obesity & Metabolic Syndrome. (1): 1-6, 2017.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Meizi He, PhD principal investigator
University of Texas at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soy supplementation in people with Central Obesity, run by The University of Texas at San Antonio at 1 site in United States.
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 5 inclusion and 7 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 10 May 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Body Fat (kg) (time frame: Study endpoint (6 months post intervention)). 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 NCT02375113, which also lists 1 linked publication.
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 10 May 2024.