Study to Evaluate the Effects of a Weight Management Program on Body Weight

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety and effectiveness of the Weight Management Program on body weight

Detailed Description
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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

Official Title
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A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effects of a Weight Management Program on Body Weight in Individuals Who Are Overweight and Otherwise Healthy

Conditions
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Body Weight

Intervention / Treatment
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* Dietary Supplement: Weight Management Formulation
* Dietary Supplement: Placebo
* Other: Handout with Suggestions for Healthy Eating and Overall Health
* Other: Handout with Suggestions for Healthy Eating and Overall Health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory, male or female, 21 - 70 years of age (volunteers between the ages of 71 and 75 inclusive will be permitted on a case-by-case basis at the discretion of the principal investigator). A body mass index (BMI) of 25-34.9 Generally healthy and having no significant difficulty with digestion or absorption of food Has been generally weight stable for the past six months (±6 lbs.) Willing and able to give written informed consent Clearly understands the procedures and study requirements Willing and able to comply with all study procedures, including following the recommendations to maintain their usual diet and regular activity, as per protocol Able to communicate, including reading, in English Have not taken any nutritional supplements that may contain any of the components of the study product for a minimum of 14 days prior to baseline screening Exclusion Criteria: Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational drug or any product containing cannabidiol (CBD) or tetrahydrocannabinol (THC) in the past 30 days Donation of blood within 30 days prior to screening/baseline Inability to provide a venous blood sample Participation in another study within 30 days prior to baseline/screening Being pregnant or planning on becoming pregnant during study participation; or breast feeding History of allergy or sensitivity to any component of the study products including saffron, dicalcium phosphate, gynostemma extract, hesperidin, microcrystalline cellulose, stearic acid, croscarmellose sodium, hydroxypropyl cellulose, vegetable cellulose, hypromellose, glycerin, silica, silicon dioxide, vegetable stearate, magnesium stearate or acacia gum Currently taking a medication or dietary supplement specifically for weight loss and unwilling to washout (i.e. stop taking) for 14 days prior to baseline Currently participating in a weight loss program and unwilling to discontinue participation prior to baseline Having been diagnosed, received medical treatment or taking medication daily for the following medical condition(s): Eating disorder (including anorexia nervosa, bulimia nervosa, binge eating disorder or avoidant or restrictive food intake disorder) Psychiatric disorder Presence of active or recurring clinically significant conditions as follows: Diabetes mellitus or other endocrine disease Eating disorder Acute or chronic inflammatory disease or autoimmune disease Cardiovascular disease including heart and blood vessel disease, arrhythmia, heart attack, stroke or heart valve problem Gastrointestinal disease including gallbladder problems, gallstones or biliary tract obstruction Thyroid disease (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study) Hypertension (unless on a stable dose of medication for 3 months prior to screening and unlikely to change medication or dose during the study) Neurologic condition/disease Cancer (unless skin cancer other than melanoma which has been treated > 3 years prior to Baseline/screening) Liver, pancreatic or kidney disease Pulmonary disease Blood coagulation disorder or other hematologic disease Other condition or medication use that would preclude participation in the study in the judgment of the investigator/sub-investigator (Sub-I) Currently taking any medications or treatment for a psychiatric disorder (bipolar disorder, manic disorder, schizophrenia, apathetic (inherited) disorder), that include antidepressant drugs, including the selective serotonin reuptake inhibitors (SSRIS), tricyclic and atypical antidepressants; benzodiazepines; central nervous system (CNS) depressants, dextromethorphan, meperidine, monoamine oxidase inhibitors (MAOIs); pentazocine, phenothiazines and tramadol. These may preclude participation in the study dependent on the judgment of the investigator/sub investigator. Currently taking or having taken within the 30 days prior to screening/baseline any hormone replacement therapy (including dehydroepiandrosterone (DHEA), estrogen, progesterone, or testosterone; except those utilized as a method of birth control and which have been taken for > 3 months, with no anticipated change for the duration of the study) Having had a surgical procedure or having an internal medical device which, in the judgment of the PI/Sub-I, would preclude participation in the study Having abnormal screening laboratory test values including bilirubin > 2.5 x upper limit of normal (ULN), aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine transaminase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85 mg/dL or > 110 mg/dL, thyroid- stimulating hormone (TSH) level < 0.450 or > 4.500 milliunits per liter (mU/L) or other lab test result(s) that would preclude study participation in the judgement of the PI/Sub-I Having blood pressure readings at Baseline/screening > 140 systolic or > 90 diastolic on two consecutive readings unless permitted to proceed to the next visit in the judgment of the PI/Sub-I Currently consumes more than 7 standard alcoholic drinks per week for women and 14 drinks per week for men (a standard alcoholic drink is defined as one bottle/can of beer, one glass of wine, or one ounce of hard liquor) Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville oranges and tangelos History of known or suspected substance abuse (e.g. alcohol, opiates, benzodiazepines or amphetamines). Having any other circumstance that precludes study participation in the judgment of the PI/Sub-I, including use of other nutritional supplements, which will be evaluated on a case-by-case basis.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Management Program<br>Dietary Supplement: Saffron extract and Gynostemma extract with hesperidin and a handout with suggestions for healthy eating and overall health | Dietary Supplement: Weight Management Formulation<br>* Saffron extract and Gynostemma extract with hesperidin<br>Other: Handout with Suggestions for Healthy Eating and Overall Health<br>* Suggestions for Healthy Eating and Overall Health<br>|
| Placebo Comparator: Placebo<br>Placebo and handout with suggestions for healthy eating and overall health | Dietary Supplement: Placebo<br>* Placebo<br>Other: Handout with Suggestions for Healthy Eating and Overall Health<br>* Suggestions for Healthy Eating and Overall Health<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the mean change in Body Weight from baseline | Mean change from baseline to Day 60 in pounds from the Body Composition Analyzer | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the mean change in Waist Circumference from baseline | Mean change from baseline to Day 60 in inches | 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. | 60 days | 
| Assessment of the mean change in the Total Cholesterol level from baseline | Mean change from baseline to Day 60 in mg/dL | 60 days | 
| Assessment of the mean change in the Triglyceride level from baseline | Mean change from baseline to Day 60 in mg/dL | 60 days | 
| Assessment of the mean change in the HDL Cholesterol level from baseline | Mean change from baseline to Day 60 in mg/dL | 60 days | 
| Assessment of the mean change in the LDL Cholesterol level from baseline | Mean change from baseline to Day 60 in mg/dL | 60 days | 
| Assessment of the mean change in the Total Cholesterol/HDL ratio from baseline | Mean change from baseline to Day 60 in ratio units | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 60 days |