Effectiveness of the Optifast Program Compared With a Reduced-energy Food Based Diet Plan on Body Weight

Completed · Not applicable

Conditions studied: Obesity

In brief

Compare percent change in loss of body weight between the OPTIFAST program and a food-based energy-deficit program

Key facts

Study ID

NCT02635698

Run by

Société des Produits Nestlé (SPN)

People needed

330

Starts

2015-11-01

Expected to finish

2017-10-01

Last updated by the study team

2017-11-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult males and females between 18 and 70 years
• Obese (BMI > 30 kg/m2 and 55 kg/m2)
• Non-smokers or smoking cessation > 6 months
• < 14 alcoholic beverages per week
• Willing and able to give informed consent

You may not qualify if…

• Active participation in any weight loss program within previous 3 months
• Weight changes of > 5% body weight within previous 3 months
• Participated in an Optifast program within prior 5 years
• Prior bariatric surgery or liposuction
• Use of any medication prescribed for weight loss in the past 3 months
• Current major disease or GI disease that is poorly controlled (Crohn's, ulcerative colitis)
• Type 1 DM
• Current ESRD
• Current COPD
• Any major or active hepatic disease requiring inpatient or outpatient treatment
• History of acute pancreatitis in the past year
• Active cancer treatment in the past 2 years other than non-malignant skin cancers
• Uncontrolled hypertension (Blood pressure 160/100 or greater)
• Hemoglobin A1c > 10%
• Recent CV event in past 6 months
• Pregnancy, childbirth, or nursing within prior 6 months
• Eating Attitudes Test (EAT-26) > 30
• Current major depressive disorder with Center for Epidemiological Studies Depression Scale-Revised (CESD-R) score > 16
• Schizophrenia, history of bipolar disorder
• Recent hospitalization for psychiatric illness in past 6 months
• Dependence on alcohol or sedative-hypnotic drugs
• Intolerance or allergy to Optifast product
• Unable to read/speak English
• Orthopedic limitation preventing participation in regular physical activity
• Untreated thyroid disease, abnormal TSH, non on stable dose of hormone replacement for hyperthyroidism

Where it is running

• Alaska Premier Health — Anchorage, Alaska, United States
• Alexian Brothers Weight Loss Solutions — Schaumburg, Illinois, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Brody School of Medicine, East Carolina University — Greenville, North Carolina, United States
• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
• Neuro-Behavioral Clinical Research, Inc. — Canton, Ohio, United States
• Central Ohio Nutrition Center, Inc. — Gahanna, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Houston Center for Clinical Research — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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