The purpose of the study is to assess the safety and effectiveness of the Weight Management Program on body weight
This is a double-blind, randomized, placebo-controlled study to evaluate the effects of a Weight Management program on body weight. Each subject will receive a specific dose of the study product (A) to be taken twice daily with breakfast and dinner and a specific dose of the study product (B) to be taken 15 minutes before lunch daily for a total of 60 days. Each subject based upon the randomization will also receive a handout with suggestions for healthy eating and overall health. Participants receive questionnaires, assessments, blood tests, vital signs and a body composition analysis. The primary objective is the assessment of the change in body weight in response to the Weight Management program relative to baseline compared with placebo The secondary objective is the assessment of the change in waist circumference, parameters from the body composition analysis, appetite, the levels of blood lipids and C-reactive protein in response to the Weight Management program relative to baseline compared with placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
54
Saffron extract and Gynostemma extract with hesperidin
Placebo
Suggestions for Healthy Eating and Overall Health
Life Extension Clinical Research, Inc.
Fort Lauderdale, Florida, United States
Assessment of the mean change in Body Weight from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in Waist Circumference from baseline
Mean change from baseline to Day 60 in inches
Time frame: 60 days
Assessment of the mean change in Appetite from baseline
Mean change in the scores on a simplified nutritional appetite questionnaire from baseline. to Day 60. A numerical scale of 1-5 is used with the sum of the individual items totaling the score. A sum of less than or equal to 14 represents an improved score in support of weight loss.
Time frame: 60 days
Assessment of the mean change in the Total Cholesterol level from baseline
Mean change from baseline to Day 60 in mg/dL
Time frame: 60 days
Assessment of the mean change in the Triglyceride level from baseline
Mean change from baseline to Day 60 in mg/dL
Time frame: 60 days
Assessment of the mean change in the HDL Cholesterol level from baseline
Mean change from baseline to Day 60 in mg/dL
Time frame: 60 days
Assessment of the mean change in the LDL Cholesterol level from baseline
Mean change from baseline to Day 60 in mg/dL
Time frame: 60 days
Assessment of the mean change in the Total Cholesterol/HDL ratio from baseline
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Suggestions for Healthy Eating and Overall Health
Mean change from baseline to Day 60 in ratio units
Time frame: 60 days
Assessment of the mean change in the Total Body Water from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the Lean Body Mass from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the Skeletal Muscle Mass from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the Body Fat Mass from baseline
Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the Extracellular Water (ECW)/Total Body Water (TBW) ratio from baseline
Mean change from baseline to Day 60 in ratio units from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the Basal Metabolic Rate from baseline
Mean change from baseline to Day 60 in kcal from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the Visceral Fat Level from baseline
Mean change from baseline to Day 60 in the level from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the Body Mass Index (BMI) from baseline
Mean change from baseline to Day 60 in (weight)kg/(height) m\^2 from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the Percent Body Fat from baseline
Mean change from baseline to Day 60 in the percent from the Body Composition Analyzer
Time frame: 60 days
Assessment of the mean change in the hs (high sensitivity)-C-reactive protein level from baseline
Mean change from baseline to Day 60 in mg/L
Time frame: 60 days