Body Weight ChangesPhase 4FORMULANCT00138645
The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
A Phase 4 study testing MicroDiet and Healthy Diet in people with Body Weight Changes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not include supplements. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight Changes
- What is being tested?
- MicroDiet and Healthy Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to May 2006
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female gender; of all ethnic backgrounds.
- Healthy person who has not been diagnosed with diabetes, cardiovascular illness, renal, hepatic or other chronic diseases
- > 17 years and < 66 years of age
- Body mass index (BMI; kg/m2) between 25 and 35
- For females with the potential to bear children, they meet one of the following criteria:
- They are willing to use an acceptable method of birth control (e.g., oral contraceptive tablets, implanted contraceptive hormones, Depo-Provera® contraceptive injections, intrauterine devices, prophylactic condoms with spermicide, contraceptive diaphragms with spermicide, cervical caps with spermicide), or are in a monogamous relationship with a partner who has had a vasectomy.
- They are sexually abstinent and intend to continue this practice, at least for the duration of the study.
Who cannot join
- > 65 years and < 18 years of age
- Regular use of medications other than birth control, vitamins or hormone replacement therapy
- Diabetes mellitus (fasting blood sugar [FBS] > 126); persons with impaired glucose tolerance (FBS 100-125) may be admitted to the study.
- Use of tobacco products
- Depression or mental illness requiring treatment or medication within the last six months
- For women, pregnancy, breast feeding, postpartum < 6 months, planning a pregnancy during the study, or are not using an acceptable method of contraception
Show all 9Show fewer
- Use of medications or herbal supplements that affect appetite or body weight for the previous three months
- Patients requiring restriction of protein intake
- Impaired kidney function (creatinine > 1.5) or liver function (liver enzymes > 3 times the upper limits of normal)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not include supplements. It is also hypothesized that the partial supplement diet will result in larger improvements in body composition, disease biomarkers, and health parameters (blood pressure, lipids) compared to the non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be significantly higher, and ratings of hunger lower, in the group consuming a partial supplement diet.
Read the detailed description
In recent decades, the prevalence of overweight and obesity has increased dramatically in developed countries. Obesity is associated with diseases such as diabetes, cardiovascular disease, hypertension, and certain cancers. Modest amounts of weight loss (e.g., 5% to 10% of initial body weight) significantly improve health and improve disease status. Recent evidence suggests that the use of supplements or meal replacements promotes greater weight loss than isocaloric food-based diets. In addition, diets that are high in protein are associated with greater ratings of satiety and reduced food intake, as well as greater weight loss, compared to lower protein diets.
The purpose of the proposed study is to test the effect of a partial supplement diet on body weight, body composition, and biomarkers for disease compared to an isocaloric diet that consists of a traditional food-based meal plan. Overweight and obese (BMI 25 to 35) participants will participate in this six-month study. The primary outcome variable is body weight loss and the secondary outcome variables include body composition, blood pressure, lipids, and subjective ratings of satiety.
- Conditions
- Body Weight Changes
- Being tested
- MicroDiet, Healthy Diet
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroDietBehavioural
MicroDiet
Healthy DietBehavioural
Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements
| Study group | Role | What they receive |
|---|---|---|
| MicroDiet | Experimental | Participants randomized to the MicroDiet group (1200 kcal/day) will be instructed by a Registered Dietitian to consume (one shake and 3 cookies; 240 kcal) for two meals each day for Months 1 through 3. They will be provided with meal plans for the meal that they do not replace with MicroDiet. During Months 4 through 6, participants in the MicroDiet group will be instructed to replace one meal per day with MD (the energy content of the meal plan will still be 1200 kcal/day). Participants will also be encouraged to eat or drink MD for snacks. The rest of the diet will consist of healthy foods, as outlined above. To help participants adhere to the MicroDiet regimen, they will meet with a registered dietitian for one hour at Week 0 and 30 minutes at Weeks 2 and 4, and every month thereafter. Receives: Behavioral: MicroDiet |
| Healthy Diet | Active comparator | Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet. The Healthy Diet will consist of the same foods that are used in the meal plans for the MicroDiet group. The Healthy Diet group will be instructed not to use meal replacements such as shakes (e.g., Slim Fast®), nutrition bars (e.g., Balance Bar®), or portion-controlled meals (e.g., Healthy Choice entrees). Receives: Behavioral: Healthy Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight Loss (kg and Percent) at Months 3 and 6
Measured: April 2005 to May 2006
Percent Change in Body Weight (Completers).
Percent change in body weight from baseline to week 24(completers).
Measured: 24 weeks
Secondary outcomes (3)
Change in Body Composition at Months 3 and 6
Measured: April 2005 to May 2006
Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6
Measured: April 2005 to May 2006
Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6
Measured: April 2005 to May 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startApr 2005
- Primary completionMay 2006
- Study completionMay 2006
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.
- Other trials for Body Weight ChangesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sunny Health Co., Ltd.
- Responsible party
- Principal investigator, Corby K. Martin, Pennington Biomedical Research Center
- Investigators
- Corby K. Martin, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138645
- Sponsor's protocol ID
- PBRC 25004
- Acronym
- FORMULA
- Status last verified
- Jan 2016
- First submitted
- 29 Aug 2005
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet
- ClinicalTrials.gov ID
- NCT00138645
- Acronym / sponsor ID
- FORMULA / PBRC 25004
- Conditions
- Body Weight Changes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Sunny Health Co., Ltd.
- Study start
- Apr 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Posted 10 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not include supplements. It is also hypothesized that the partial supplement diet will result in larger improvements in body composition, disease biomarkers, and health parameters (blood pressure, lipids) compared to the non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be significantly higher, and ratings of hunger lower, in the group consuming a partial supplement diet.
Detailed description
In recent decades, the prevalence of overweight and obesity has increased dramatically in developed countries. Obesity is associated with diseases such as diabetes, cardiovascular disease, hypertension, and certain cancers. Modest amounts of weight loss (e.g., 5% to 10% of initial body weight) significantly improve health and improve disease status. Recent evidence suggests that the use of supplements or meal replacements promotes greater weight loss than isocaloric food-based diets. In addition, diets that are high in protein are associated with greater ratings of satiety and reduced food intake, as well as greater weight loss, compared to lower protein diets.
The purpose of the proposed study is to test the effect of a partial supplement diet on body weight, body composition, and biomarkers for disease compared to an isocaloric diet that consists of a traditional food-based meal plan. Overweight and obese (BMI 25 to 35) participants will participate in this six-month study. The primary outcome variable is body weight loss and the secondary outcome variables include body composition, blood pressure, lipids, and subjective ratings of satiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MicroDiet | Experimental | Behavioral: MicroDietParticipants randomized to the MicroDiet group (1200 kcal/day) will be instructed by a Registered Dietitian to consume (one shake and 3 cookies; 240 kcal) for two meals each day for Months 1 through 3. They will be provided with meal plans for the meal that they do not replace with MicroDiet. During Months 4 through 6, participants in the MicroDiet group will be instructed to replace one meal per day with MD (the energy content of the meal plan will still be 1200 kcal/day). Participants will also be encouraged to eat or drink MD for snacks. The rest of the diet will consist of healthy foods, as outlined above. To help participants adhere to the MicroDiet regimen, they will meet with a registered dietitian for one hour at Week 0 and 30 minutes at Weeks 2 and 4, and every month thereafter. |
| Healthy Diet | Active comparator | Behavioral: Healthy DietParticipants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet. The Healthy Diet will consist of the same foods that are used in the meal plans for the MicroDiet group. The Healthy Diet group will be instructed not to use meal replacements such as shakes (e.g., Slim Fast®), nutrition bars (e.g., Balance Bar®), or portion-controlled meals (e.g., Healthy Choice entrees). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female gender; of all ethnic backgrounds.
- Healthy person who has not been diagnosed with diabetes, cardiovascular illness, renal, hepatic or other chronic diseases
- > 17 years and < 66 years of age
- Body mass index (BMI; kg/m2) between 25 and 35
- For females with the potential to bear children, they meet one of the following criteria:
Key exclusion criteria (9 listed)
- > 65 years and < 18 years of age
- Regular use of medications other than birth control, vitamins or hormone replacement therapy
- Diabetes mellitus (fasting blood sugar [FBS] > 126); persons with impaired glucose tolerance (FBS 100-125) may be admitted to the study.
- Use of tobacco products
- Depression or mental illness requiring treatment or medication within the last six months
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 |
|---|---|---|
| MicroDietMicroDiet | Behavioural | MicroDiet |
| Healthy DietParticipants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements | Behavioural | Healthy Diet |
Primary outcome
Body Weight Loss (kg and Percent) at Months 3 and 6
Time frame: April 2005 to May 2006
Percent Change in Body Weight (Completers).
Time frame: 24 weeks
Percent change in body weight from baseline to week 24(completers).
3 secondary outcomes
Change in Body Composition at Months 3 and 6
Time frame: April 2005 to May 2006
Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6
Time frame: April 2005 to May 2006
Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6
Time frame: April 2005 to May 2006
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Corby K. Martin, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MicroDiet and Healthy Diet in people with Body Weight Changes, run by Pennington Biomedical Research Center 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 7 inclusion and 9 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 8 Feb 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2009). 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 Weight Loss (kg and Percent) at Months 3 and 6 (time frame: April 2005 to May 2006). The study lists 2 primary outcomes in all. 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 8 Feb 2016.