A Comparative Effectiveness Study Evaluating the Effects of Thermogenic Supplements on Body Composition

Study Overview
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Brief Summary
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The purpose of this study is to determine whether subjects taking a supplement designed to increase metabolic rate will have a positive effect on body composition (fat mass, muscle mass, and bone density.)

Detailed Description
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In a previous randomized double-blinded placebo-controlled pilot study, subjects taking the nutritional supplements contained in these two weight loss plans had a short-term statistically significant increase in their resting metabolic rates as compared to taking a placebo. No increases were found in blood pressure, resting heart rate, or self-reported discomfort when taking the supplement. The current study was designed to extend the findings of the pilot study over a 60-day study period using a randomized double-blinded placebo-controlled protocol with the same weight loss interventions.

Official Title
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A Comparative Effectiveness Study Evaluating the Effects of Two Thermogenic Supplements on Body Composition Using a Double-Blinded Placebo-Controlled Protocol

Conditions
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Weight Loss

Intervention / Treatment
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* Dietary Supplement: Advantra Z
* Dietary Supplement: Advantra Z + Naringin + Hesperiden
* Other: Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must ensure with medical provider that there are no medical conditions that would preclude participation Must be able to swallow capsules Must be age 21 or above Exclusion Criteria: Pregnant or breast feeding

Ages Eligible for Study
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Minimum Age: 21 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Advantra Z<br>Proprietary ingredient for: stimulating thermogenesis, reducing weight, increasing lean muscle mass to total body mass, improving athletic performance, and suppressing appetite | Dietary Supplement: Advantra Z<br>* Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine.<br>* Other names: p-synephrine;|
| Active Comparator: Advantra Z + Naringin + Hesperiden<br> | Dietary Supplement: Advantra Z + Naringin + Hesperiden<br>* Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine, 600 mg naringin, and 100 mg hesperiden.<br>* Other names: Hesperiden;|
| Placebo Comparator: Sugar pill<br>Capsule contains inert ingredient. | Other: Sugar pill<br>* Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA) | This study goes beyond assessing changes in scale weight and BMI. DXA is used to assess changes in body composition (lean, fat and bone) associated with the weight loss interventions. | 0 and 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 43-item blood chemistry panel | 43 chemistries including Lipids, CBC, Metabolic panel, TSH, and Cardio CrP | 0 and 60 days | 
| Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days | Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 30 of study. | 0 and 30 days | 
| Change from Baseline in Resting Heart Rate at 30 days | Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 30 of study. | 0 and 30 days | 
| Change from midpoint of study in Resting Heart Rate at 60 days | Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between day 30 and 60 of study. | 30 and 60 days | 
| Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days | Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 60 of study. | 0 and 60 days | 
| Change from Baseline in Resting Heart Rate at 60 days | Measure of heart rate after sitting or lying down for at least 5 minutes. Changes will be reported between baseline and day 60 of study. | 0 and 60 days | 
| Change from Baseline in self-reported quality of life at 30 days. |  | 0 and 30 days | 
| Change from mid-point of study in self-reported quality of life at 60 days. |  | 30 and 60 days | 
| Change from Baseline in self-reported quality of life at 60 days. |  | 0 and 60 days | 
| Change from Baseline in self-reported eating behavior at 30 days. | A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior | 0 and 30 days | 
| Change from mid-point of study in self-reported eating behavior at 60 days | A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior | 30 and 60 days | 
| Change from Baseline in self-reported eating behavior at 60 days. | A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior | 0 and 60 days | 
| Change from mid-point of study in Systolic and Diastolic Blood Pressure at 60 days | Measures the amount of force (pressure) that blood exerts on the walls of the blood vessels as it passes through them. Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic pressure is a measure of blood pressure while the heart is relaxed, between heartbeats. Measurements will be taken after sitting or lying down for at least 5 minutes. Changes will be reported between mid-point and day 60 of study. | 30 and 60 days | 
| Number of participants with adverse events | Participants will have opportunity to report on a daily basis any adverse events experienced. | up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Body Composition, Fat Free Mass, Bone Mineral Density, Adipose Tissue, Dual-Energy X-Ray Absorptiometry, Body Fat, Eating and appetite control, Basal Metabolic Rate