ObesityNCT01011491
Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories
A study testing Medifast 5 & 1 Plan for weight loss and weight maintenance and Food-based diet plan for weight loss and weight maintenance in people with Obesity, run by Medifast, Inc. at 1 site in United States.
Trial summary
Portion-controlled meal replacements have been shown to be an effective weight control strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the effect of Medifast's 5 \& 1 program compared to an food-based diet plan of equal calories on the following indices: weight loss and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Medifast 5 & 1 Plan for weight loss and weight maintenance and Food-based diet plan for weight loss and weight maintenance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Sep 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females (age between 18 and 65)
- Obese (BMI >=30.0 kg/m2 and <50.0 kg/m2)
- Non-smokers
- No known food allergies to wheat, gluten, soy or nuts
- <14 alcoholic beverages per week
- Willing and able to give informed consent
Show all 9Show fewer
- Not currently using appetite-affecting medications (e.g SSRIs, steroids, Ritalin)
- Not pregnant or lactating
- Primary care physician's permission for weight loss, normal labs and electrocardiogram (EKG) within past 1 year
Who cannot join
- Actively dieting
- Eating Attitudes Test (EAT) > 30
- Chronic uncontrolled health problems (not including obesity or diabetes)
- Pacemaker or other internal electronic medical device
- Schizophrenia, history of bipolar disorder, current Major Depressive Disorder
- Dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines)
Show all 11Show fewer
- Cognitive impairment severe enough to preclude informed consent
- Taking weight loss or appetite-suppressant medications
- Taking appetite affecting medications (e.g. SSRIs, steroids, Ritalin)
- Food allergies to wheat, gluten, soy, or nuts
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Medifast's 5 & 1 Program Compared to a Food-based Diet After a Period of Weight Loss and Weight Maintenance
Portion-controlled meal replacements have been shown to be an effective weight control strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the effect of Medifast's 5 \& 1 program compared to an food-based diet plan of equal calories on the following indices: weight loss and maintenance of weight loss, satiety during weight loss, changes in biochemical markers of inflammation and oxidative stress following weight loss, and compliance and retention rates.
- Conditions
- Obesity
- Being tested
- Medifast 5 & 1 Plan for weight loss and weight maintenance, Food-based diet plan for weight loss and weight maintenance
- Keywords
- Obesity, Weight loss, meal replacements, inflammation, oxidative stress, visceral fat
- Medical subject headings
- Obesity, Weight Loss, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medifast 5 & 1 Plan for weight loss and weight maintenanceOther
Medifast's 5 \& 1 Plan is a meal replacement program for weight loss that uses 5 Medifast meals and 1 self-prepared meal. The weight maintenance plan incorporates 3-5 Medifast meals as well as a certain amount of food from all other food groups.
Food-based diet plan for weight loss and weight maintenanceOther
The food-based group was provided a meal plan for weight loss based on the guidelines of the USDA Food Guide Pyramid providing the same number of calories as the Medifast 5 \& 1 Plan. Weight maintenance calories were calculated and participants were provided meal plans from the USDA Food Guide Pyramid.
| Study group | Role | What they receive |
|---|---|---|
| Medifast 5 & 1 Plan | Experimental | Medifast's 5 \& 1 Plan is a meal replacement plan for weight loss and weight maintenance. Receives: Other: Medifast 5 & 1 Plan for weight loss and weight maintenance |
| Food-based | Active comparator | The food-based arm followed a meal plan of self-selected foods that provided the same number of calories as the Medifast 5 \& 1 plan. Receives: Other: Food-based diet plan for weight loss and weight maintenance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight change (in kilograms) from week 0
Measured: 16 weeks
Secondary outcomes (11)
Satiety using a visual analog scale
Measured: 16 weeks
Change in Inflammation represented by C-reactive protein
Measured: 16 and 40 weeks
Change in Oxidative Stress represented by urine lipid peroxides
Measured: 16 and 40 weeks
Blood Pressure change
Measured: 16 and 40 weeks
Change in Pulse
Measured: 16 and 40 weeks
Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms)
Measured: 24 weeks
Change in percent body fat (a measure representing a change in body composition)
Measured: 16 and 40 weeks
Change in Blood lipids
Measured: 16 and 40 weeks
Change in lean muscle mass (a measure representing change in body composition)
Measured: 16 and 40 weeks
Change in Waist circumference (a measure representing change in body composition)
Measured: 16 and 40 weeks
Change in Visceral Fat Rating (a measure representing change in body composition)
Measured: 16 and 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startMar 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medifast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lisa M Davis, PhD, PA-C, Principal investigator, Medifast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011491
- Sponsor's protocol ID
- MED014
- Other IDs
- 20080292
- Status last verified
- Nov 2009
- First submitted
- 10 Nov 2009
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Thearle M, Aronne LJ. Obesity and pharmacologic therapy. Endocrinol Metab Clin North Am. 2003 Dec;32(4):1005-24. doi: 10.1016/s0889-8529(03)00066-5.
PubMed 14711072Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
PubMed 15199035Gale SM, Castracane VD, Mantzoros CS. Energy homeostasis, obesity and eating disorders: recent advances in endocrinology. J Nutr. 2004 Feb;134(2):295-8. doi: 10.1093/jn/134.2.295.
PubMed 14747663de Ferranti S, Rifai N. C-reactive protein and cardiovascular disease: a review of risk prediction and interventions. Clin Chim Acta. 2002 Mar;317(1-2):1-15. doi: 10.1016/s0009-8981(01)00797-5.
PubMed 11814453Festi D, Colecchia A, Sacco T, Bondi M, Roda E, Marchesini G. Hepatic steatosis in obese patients: clinical aspects and prognostic significance. Obes Rev. 2004 Feb;5(1):27-42. doi: 10.1111/j.1467-789x.2004.00126.x.
PubMed 14969505Abbott RD, Ross GW, White LR, Nelson JS, Masaki KH, Tanner CM, Curb JD, Blanchette PL, Popper JS, Petrovitch H. Midlife adiposity and the future risk of Parkinson's disease. Neurology. 2002 Oct 8;59(7):1051-7. doi: 10.1212/wnl.59.7.1051.
PubMed 12370461Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.
PubMed 12704397Visser M, Bouter LM, McQuillan GM, Wener MH, Harris TB. Elevated C-reactive protein levels in overweight and obese adults. JAMA. 1999 Dec 8;282(22):2131-5. doi: 10.1001/jama.282.22.2131.
PubMed 10591334Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972.
PubMed 10195925Tchernof A, Nolan A, Sites CK, Ades PA, Poehlman ET. Weight loss reduces C-reactive protein levels in obese postmenopausal women. Circulation. 2002 Feb 5;105(5):564-9. doi: 10.1161/hc0502.103331.
PubMed 11827920Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
PubMed 15599400Stefanovic A, Kotur-Stevuljevic J, Spasic S, Bogavac-Stanojevic N, Bujisic N. The influence of obesity on the oxidative stress status and the concentration of leptin in type 2 diabetes mellitus patients. Diabetes Res Clin Pract. 2008 Jan;79(1):156-63. doi: 10.1016/j.diabres.2007.07.019. Epub 2007 Sep 11.
PubMed 17850913Vincent HK, Morgan JW, Vincent KR. Obesity exacerbates oxidative stress levels after acute exercise. Med Sci Sports Exerc. 2004 May;36(5):772-9. doi: 10.1249/01.mss.0000126576.53038.e9.
PubMed 15126709Ashley JM, Herzog H, Clodfelter S, Bovee V, Schrage J, Pritsos C. Nutrient adequacy during weight loss interventions: a randomized study in women comparing the dietary intake in a meal replacement group with a traditional food group. Nutr J. 2007 Jun 25;6:12. doi: 10.1186/1475-2891-6-12.
PubMed 17592648Ditschuneit HH, Flechtner-Mors M. Value of structured meals for weight management: risk factors and long-term weight maintenance. Obes Res. 2001 Nov;9 Suppl 4:284S-289S. doi: 10.1038/oby.2001.132.
PubMed 11707555
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Medifast's 5 & 1 Program Compared to a Food-based Diet After a Period of Weight Loss and Weight Maintenance
- ClinicalTrials.gov ID
- NCT01011491
- Acronym / sponsor ID
- MED014
- Conditions
- Obesity
- Keywords
- Obesity, Weight loss, meal replacements, inflammation, oxidative stress, visceral fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medifast, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 11 Nov 2009 (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.
Portion-controlled meal replacements have been shown to be an effective weight control strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the effect of Medifast's 5 \& 1 program compared to an food-based diet plan of equal calories on the following indices: weight loss and maintenance of weight loss, satiety during weight loss, changes in biochemical markers of inflammation and oxidative stress following weight loss, and compliance and retention rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medifast 5 & 1 Plan | Experimental | Other: Medifast 5 & 1 Plan for weight loss and weight maintenanceMedifast's 5 \& 1 Plan is a meal replacement plan for weight loss and weight maintenance. |
| Food-based | Active comparator | Other: Food-based diet plan for weight loss and weight maintenanceThe food-based arm followed a meal plan of self-selected foods that provided the same number of calories as the Medifast 5 \& 1 plan. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult males and females (age between 18 and 65)
- Obese (BMI >=30.0 kg/m2 and <50.0 kg/m2)
- Non-smokers
- No known food allergies to wheat, gluten, soy or nuts
- <14 alcoholic beverages per week
Key exclusion criteria (11 listed)
- Actively dieting
- Eating Attitudes Test (EAT) > 30
- Chronic uncontrolled health problems (not including obesity or diabetes)
- Pacemaker or other internal electronic medical device
- Schizophrenia, history of bipolar disorder, current Major Depressive Disorder
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 5 & 1 Plan for weight loss and weight maintenanceMedifast's 5 \& 1 Plan is a meal replacement program for weight loss that uses 5 Medifast meals and 1 self-prepared meal. The weight maintenance plan incorporates 3-5 Medifast meals as well as a certain amount of food from all other food groups. | Other | Medifast 5 & 1 Plan |
| Food-based diet plan for weight loss and weight maintenanceThe food-based group was provided a meal plan for weight loss based on the guidelines of the USDA Food Guide Pyramid providing the same number of calories as the Medifast 5 \& 1 Plan. Weight maintenance calories were calculated and participants were provided meal plans from the USDA Food Guide Pyramid. | Other | Food-based |
Primary outcome
Weight change (in kilograms) from week 0
Time frame: 16 weeks
11 secondary outcomes
Satiety using a visual analog scale
Time frame: 16 weeks
Change in Inflammation represented by C-reactive protein
Time frame: 16 and 40 weeks
Change in Oxidative Stress represented by urine lipid peroxides
Time frame: 16 and 40 weeks
Blood Pressure change
Time frame: 16 and 40 weeks
Change in Pulse
Time frame: 16 and 40 weeks
Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms)
Time frame: 24 weeks
Change in percent body fat (a measure representing a change in body composition)
Time frame: 16 and 40 weeks
Change in Blood lipids
Time frame: 16 and 40 weeks
Change in lean muscle mass (a measure representing change in body composition)
Time frame: 16 and 40 weeks
Change in Waist circumference (a measure representing change in body composition)
Time frame: 16 and 40 weeks
Change in Visceral Fat Rating (a measure representing change in body composition)
Time frame: 16 and 40 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 11 Nov 2009.
- Background: PubMed 14711072Thearle M, Aronne LJ. Obesity and pharmacologic therapy. Endocrinol Metab Clin North Am. 2003 Dec;32(4):1005-24. doi: 10.1016/s0889-8529(03)00066-5.
- Background: PubMed 15199035Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847.
- Background: PubMed 14747663Gale SM, Castracane VD, Mantzoros CS. Energy homeostasis, obesity and eating disorders: recent advances in endocrinology. J Nutr. 2004 Feb;134(2):295-8. doi: 10.1093/jn/134.2.295.
- Background: PubMed 11814453de Ferranti S, Rifai N. C-reactive protein and cardiovascular disease: a review of risk prediction and interventions. Clin Chim Acta. 2002 Mar;317(1-2):1-15. doi: 10.1016/s0009-8981(01)00797-5.
- Background: PubMed 14969505Festi D, Colecchia A, Sacco T, Bondi M, Roda E, Marchesini G. Hepatic steatosis in obese patients: clinical aspects and prognostic significance. Obes Rev. 2004 Feb;5(1):27-42. doi: 10.1111/j.1467-789x.2004.00126.x.
- Background: PubMed 12370461Abbott RD, Ross GW, White LR, Nelson JS, Masaki KH, Tanner CM, Curb JD, Blanchette PL, Popper JS, Petrovitch H. Midlife adiposity and the future risk of Parkinson's disease. Neurology. 2002 Oct 8;59(7):1051-7. doi: 10.1212/wnl.59.7.1051.
- Background: PubMed 12704397Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.
- Background: PubMed 10591334Visser M, Bouter LM, McQuillan GM, Wener MH, Harris TB. Elevated C-reactive protein levels in overweight and obese adults. JAMA. 1999 Dec 8;282(22):2131-5. doi: 10.1001/jama.282.22.2131.
- Background: PubMed 10195925Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972.
- Background: PubMed 11827920Tchernof A, Nolan A, Sites CK, Ades PA, Poehlman ET. Weight loss reduces C-reactive protein levels in obese postmenopausal women. Circulation. 2002 Feb 5;105(5):564-9. doi: 10.1161/hc0502.103331.
- Background: PubMed 15599400Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
- Background: PubMed 17850913Stefanovic A, Kotur-Stevuljevic J, Spasic S, Bogavac-Stanojevic N, Bujisic N. The influence of obesity on the oxidative stress status and the concentration of leptin in type 2 diabetes mellitus patients. Diabetes Res Clin Pract. 2008 Jan;79(1):156-63. doi: 10.1016/j.diabres.2007.07.019. Epub 2007 Sep 11.
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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.
Lisa M Davis, PhD, PA-C principal investigator
Medifast, Inc.
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 5 & 1 Plan for weight loss and weight maintenance and Food-based diet plan for weight loss and weight maintenance in people with Obesity, run by Medifast, Inc. 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 11 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 11 Nov 2009. 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?
Weight change (in kilograms) from week 0 (time frame: 16 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 NCT01011491, which also lists 18 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 11 Nov 2009.