Abdominal ObesitySILVERNCT01298817
Use of a Soy-based Meal Replacement Weight Loss Intervention to Impact Ectopic Fat
A study testing Medifast meal replacement products in people with Abdominal Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The main objectives of this study are to collect pilot data to assess feasibility (accrual, retention, compliance), to estimate the variability of outcome measures, and to obtain preliminary estimates of treatment efficacy based on group differences in body composition (decreases in ectopic fat stores while… Read more about this study
- Who is it for?
- Ages 60 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Medifast meal replacement products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Dec 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 60 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age = 60-79 years old
- BMI ≥ 27 kg/m2
- Waist Circumference= men ≥ 102 cm; women ≥ 88 cm
- Non-impaired cognitive function (MMSE > 21)
- Willing to provide informed consent
- No contraindications for participation in weight loss
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- Able to provide own transportation to study visits and intervention
- Willing to consume meal replacement products (i.e. no soy/dairy allergies, product found to be palatable)
- Not involved in any other research study
Who cannot join
- Weight loss or gain (±5%) in past 6 months
- Body mass > 136 kg (DXA limit)
- Regular smoker (> 1 cigarette/day) within past year
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)
- Insulin-dependent or uncontrolled diabetes (FPG ≥ 126 mg/dL)
- Self-reported hepatitis
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- Abnormal kidney function (creatinine > 2.0)
- Abnormal liver blood test (AST, ALT, total bilirubin- greater than twice the upper limit of normal; albumin - less than 2.0)
- Unstable angina
- MI, PCI or cardiac surgery < 3 month ago
- Uncontrolled blood pressure (> 160/90 mmHg)
- Chronic pulmonary disease (> mild or recent exacerbations)
- Thyroid disease
- Known significant hematological disease (including HBG < 11)
- Active known cancer requiring treatment in past year (except non-melanoma skin cancers)
- Life expectancy < 2 years
- Regular use of any medications that could influence study variables (growth/steroid hormones, including estrogen replacements, thiazolidinediones, statins, regular anti-inflammatory medications, weight loss medications, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: Use of a Soy-based Meal Replacement Weight Loss Intervention to Impact Ectopic Fat and Associated Cardio-metabolic Risk in Obese, Older Adults: A Feasibility Study
The main objectives of this study are to collect pilot data to assess feasibility (accrual, retention, compliance), to estimate the variability of outcome measures, and to obtain preliminary estimates of treatment efficacy based on group differences in body composition (decreases in ectopic fat stores while maintaining lean mass), cardio-metabolic risk factors including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6), blood pressure and lipids (HDL, LDL, TC, TG), and measures of physical function and muscle strength. While this is just a pilot study, randomization will be used so that the investigators can obtain a realistic estimate of accrual (which is often less in a randomized trial) and an unbiased estimate of treatment efficacy.
The investigators will accomplish these objectives by conducting a 2-arm, 3-month randomized, clinical trial in 24 older (60-79), abdominally obese (BMI ≥30 kg/m2 and waist circumference ≥ 102 cm and ≥ 88 cm in men and women, respectively) men and women. Participants will be randomized to a soy-based or animal-based, 3-month, hypocaloric dietary intervention to achieve our specific aims:
Read more
Primary Aim: To determine our ability to recruit and retain older, obese adults to a 3 month soy-based meal replacement weight loss intervention and assess the study participant's ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones).
Secondary Aims:
- To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on measures of body composition, including abdominal (total, subcutaneous and visceral fat), liver, and pericardial fat; anthropometrics (body weight, waist/hip circumference); and whole body fat and lean mass.
- To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on biomarkers of cardiometabolic risk including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6), blood pressure and lipids (HDL, LDL, TC, TG).
- To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on physical function (short physical performance battery, 400-m walk) and muscle strength (grip and knee extensor strength) and size (CT thigh muscle).
- To document any adverse events associated with the soy-based meal replacement.
- Conditions
- Abdominal Obesity
- Being tested
- Medifast meal replacement products
- Keywords
- Obesity, Aging, Soy, Weight Loss, Ectopic Fat
- Medical subject headings
- Obesity, Abdominal, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medifast meal replacement productsDietary supplement
Also called Soy
A total of 4 meal replacement (MR)products per participant per day will be used. Approximately 2/3rd of the Medifast® MR product line is soy protein-based (i.e. at least 7 g of total protein coming from soy) with the remaining 1/3rd of items deriving total protein content from animal sources (whey and egg). The soy used in Medifast products is Solae SUPRO® water-washed soy protein isolate. Depending on seasonal variations, soy MR products contain approximately 1.5-3.0 milligrams of soy isoflavones for every 1 gram of soy protein. Thus, participants in the soy treatment arm will consume at least 28 g/soy protein and 42-108 mg/isoflavones per day.
Medifast meal replacement productsDietary supplement
Also called whey
A total of 4 meal replacement (MR)products per participant per day will be used. Approximately 2/3rd of the Medifast® MR product line is soy protein-based (i.e. at least 7 g of total protein coming from soy) with the remaining 1/3rd of items deriving total protein content from animal sources (whey and egg). This group will receive the non soy supplements.
| Study group | Role | What they receive |
|---|---|---|
| Soy, Prepared Meals | Experimental | Soy-based meal replacement weight loss group with additional meals provided Receives: Dietary Supplement: Medifast meal replacement products |
| Non soy prepared meals | Active comparator | Non-soy based meal replacement weight loss group with additional meals provided Receives: Dietary Supplement: Medifast meal replacement products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Compliance
To determine our ability to recruit and retain older, obese adults to a 3 month soy-based meal replacement weight loss intervention and assess the study participant's ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones).
Measured: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up
Secondary outcomes (4)
Change in Body Composition
To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on measures of body composition, including abdominal (total, subcutaneous and visceral fat), liver, and pericardial fat; anthropometrics (body weight, waist/hip circumference); and whole body fat and lean mass.
Measured: Baseline and at the 12-week follow up
Change in Cardiometabolic Health
To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on biomarkers of cardiometabolic risk including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6), blood pressure and lipids (HDL, LDL, TC, TG).
Measured: Baseline and at the 12-week follow up
Change in Physical Function
To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on physical function (short physical performance battery, 400-m walk) and muscle strength (grip and knee extensor strength) and size (CT thigh muscle).
Measured: Baseline and at the 12 week follow up
Number of participants with adverse events as a measure of safety and tolerability
To document any adverse events associated with the soy-based meal replacement.
Measured: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mara Vitolins, DrPH, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298817
- Sponsor's protocol ID
- IRB00015659
- Acronym
- SILVER
- Status last verified
- Aug 2018
- First submitted
- 17 Feb 2011
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Soy-based Meal Replacement Weight Loss Intervention to Impact Ectopic Fat and Associated Cardio-metabolic Risk in Obese, Older Adults: A Feasibility Study
- ClinicalTrials.gov ID
- NCT01298817
- Acronym / sponsor ID
- SILVER / IRB00015659
- Conditions
- Abdominal Obesity
- Keywords
- Obesity, Aging, Soy, Weight Loss, Ectopic Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Feb 2011 (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 main objectives of this study are to collect pilot data to assess feasibility (accrual, retention, compliance), to estimate the variability of outcome measures, and to obtain preliminary estimates of treatment efficacy based on group differences in body composition (decreases in ectopic fat stores while maintaining lean mass), cardio-metabolic risk factors including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6), blood pressure and lipids (HDL, LDL, TC, TG), and measures of physical function and muscle strength. While this is just a pilot study, randomization will be used so that the investigators can obtain a realistic estimate of accrual (which is often less in a randomized trial) and an unbiased estimate of treatment efficacy.
The investigators will accomplish these objectives by conducting a 2-arm, 3-month randomized, clinical trial in 24 older (60-79), abdominally obese (BMI ≥30 kg/m2 and waist circumference ≥ 102 cm and ≥ 88 cm in men and women, respectively) men and women. Participants will be randomized to a soy-based or animal-based, 3-month, hypocaloric dietary intervention to achieve our specific aims:
Primary Aim: To determine our ability to recruit and retain older, obese adults to a 3 month soy-based meal replacement weight loss intervention and assess the study participant's ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones).
Secondary Aims:
- To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on measures of body composition, including abdominal (total, subcutaneous and visceral fat), liver, and pericardial fat; anthropometrics (body weight, waist/hip circumference); and whole body fat and lean mass.
- To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on biomarkers of cardiometabolic risk including glucoregulatory function (glucose, insulin), inflammation (C-reactive protein, IL-6), blood pressure and lipids (HDL, LDL, TC, TG).
- To estimate the variability of and obtain preliminary estimates of the effect of the soy-based meal replacement on physical function (short physical performance battery, 400-m walk) and muscle strength (grip and knee extensor strength) and size (CT thigh muscle).
- To document any adverse events associated with the soy-based meal replacement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy, Prepared Meals | Experimental | Dietary Supplement: Medifast meal replacement productsSoy-based meal replacement weight loss group with additional meals provided |
| Non soy prepared meals | Active comparator | Dietary Supplement: Medifast meal replacement productsNon-soy based meal replacement weight loss group with additional meals provided |
Who may qualify
- Ages
- 60 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age = 60-79 years old
- BMI ≥ 27 kg/m2
- Waist Circumference= men ≥ 102 cm; women ≥ 88 cm
- Non-impaired cognitive function (MMSE > 21)
- Willing to provide informed consent
Key exclusion criteria (17 listed)
- Weight loss or gain (±5%) in past 6 months
- Body mass > 136 kg (DXA limit)
- Regular smoker (> 1 cigarette/day) within past year
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)
- Insulin-dependent or uncontrolled diabetes (FPG ≥ 126 mg/dL)
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 |
|---|---|---|
| Medifast meal replacement productsAlso: SoyA total of 4 meal replacement (MR)products per participant per day will be used. Approximately 2/3rd of the Medifast® MR product line is soy protein-based (i.e. at least 7 g of total protein coming from soy) with the remaining 1/3rd of items deriving total protein content from animal sources (whey and egg). The soy used in Medifast products is Solae SUPRO® water-washed soy protein isolate. Depending on seasonal variations, soy MR products contain approximately 1.5-3.0 milligrams of soy isoflavones for every 1 gram of soy protein. Thus, participants in the soy treatment arm will consume at least 28 g/soy protein and 42-108 mg/isoflavones per day. | Dietary supplement | Soy, Prepared Meals |
| Medifast meal replacement productsAlso: wheyA total of 4 meal replacement (MR)products per participant per day will be used. Approximately 2/3rd of the Medifast® MR product line is soy protein-based (i.e. at least 7 g of total protein coming from soy) with the remaining 1/3rd of items deriving total protein content from animal sources (whey and egg). This group will receive the non soy supplements. | Dietary supplement | Non soy prepared meals |
Primary outcome
Protocol Compliance
Time frame: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up
To determine our ability to recruit and retain older, obese adults to a 3 month soy-based meal replacement weight loss intervention and assess the study participant's ability to adhere to the intervention protocol (weight, compliance logs, serum isoflavones).
4 secondary outcomes
Change in Body Composition
Time frame: Baseline and at the 12-week follow up
Change in Cardiometabolic Health
Time frame: Baseline and at the 12-week follow up
Change in Physical Function
Time frame: Baseline and at the 12 week follow up
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up
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 15 Aug 2018.
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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.
Mara Vitolins, DrPH principal investigator
Wake Forest 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 Medifast meal replacement products in people with Abdominal Obesity, run by Wake Forest University Health Sciences 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 9 inclusion and 17 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 15 Aug 2018. 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. 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?
Protocol Compliance (time frame: Baseline, weekly (1 time per week for 11 weeks), and at 12 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2018.