Effect of Orlistat in Body Composition
Condition: Obesity; Overweight
MeSH terms: Overweight
Intervention: Orlistat; Placebo
Intervention description: Weight loss treatment; Inactive
Intervention MeSH terms: Orlistat
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: overweight, orlistat, body composition

Summary:

      The purpose of this study is to determine if a 24 week weight loss program with orlistat 60
      mg will produce greater changes in body composition compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-60 years inclusive

          -  Body Mass Index (BMI): BMI in the range of 25.0-34.9 kg/m^2

          -  Waist circumference:

        Females: > 35 inches Males: > 40 inches

          -  Diet:

               1. Normal eating habits, consuming 3 meals a day (breakfast, lunch and dinner)

               2. Willing to follow a hypocaloric diet during the study to achieve weight loss

               3. Willing to take a daily multivitamin for the duration of the study.

          -  General Health:Good general health with (in the opinion of the investigator) no
             clinically significant and relevant abnormalities of medical history or physical
             examination

        Exclusion Criteria:

          -  Pregnant and/ or Breast-feeding women

          -  Diet/Exercise:Currently on a special diet or who cannot fulfill the dietary
             requirements of the study.

          -  Smoking History:a) Smoking cessation within the past 6 months b) Current Smokers

          -  Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study
             materials and study foods (or closely related compounds) or any of their stated
             ingredients.

          -  Medication:

             a) Currently taking medication for weight loss or appetite control. b) Previous
             Xenical® (orlistat) or alli® use within 3 months of screening date c) Currently taking
             medication or supplements that influence intestinal transit time and other stool
             formation parameters or influences cramping (e.g., Anticholinergics (such as atropine)
             or cholinergics (such as physostigmine), phenothiazines, tricyclic antidepressants,
             opioid analgesics (including loperamide), calcium channel antagonists, clonidine,
             cisapride, octreotide. Also, any laxative or antidiarrheal product). d) Currently
             taking or withdrawn during the past 6 months any drugs with significant impact on body
             weight (e.g. serotoninergically acting drugs, antidepressants, central adrenergically
             acting drugs, drugs inhibiting digestion and absorption, appetite suppressants,
             metformin) e) Currently taking Cyclosporine, Warfarin or Amiodarone HCL

          -  Disease/Surgery:

             a) History of gastrointestinal disease (e.g., irritable bowel syndrome, diarrhea,
             inflamed bowel, steatorrhea/fat malabsorption, hemorrhoids, incontinence,
             pancreatitis). b) History of psychological disorder, including eating disorders such
             as anorexia nervosa and bulimia c) History of neurological disorder (e.g. seizures,
             parkinson's disease, Alzheimer's disease) d) History of hypo/hyperthyroidism unless
             euthyroid and controlled on a stable dose of medication for at least 6 months. e)
             History of surgery for weight loss f) Uncontrolled hypertension g) Heart Disease h)
             Diabetes Mellitus (Type 1 and 2) (Fasting Blood Glucose >126 mg/dL)

          -  Participant has a known history of panic attacks and/or claustrophobia or other
             conditions precluding safe EchoMRI, CT or other scanning modalities according to local
             guidelines, (e.g., pacemaker, hearing aid, metallic body piercing and/or other metal
             implants) or in the opinion of the Investigator the participant exceeds size
             limitations for the instruments.

          -  Participant has had a weight loss or gain of greater than or equal to 3 kg in the 3
             months prior to screening.