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

• 43-item blood chemistry panel [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
  43 chemistries including Lipids, CBC, Metabolic panel, TSH, and Cardio CrP
• Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days [ Time Frame: 0 and 30 days ] [ Designated as safety issue: Yes ]
  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.
• Change from Baseline in Resting Heart Rate at 30 days [ Time Frame: 0 and 30 days ] [ Designated as safety issue: Yes ]
  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.
• Change from midpoint of study in Resting Heart Rate at 60 days [ Time Frame: 30 and 60 days ] [ Designated as safety issue: Yes ]
  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.
• Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
  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.
• Change from Baseline in Resting Heart Rate at 60 days [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
  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.
• Change from Baseline in self-reported quality of life at 30 days. [ Time Frame: 0 and 30 days ] [ Designated as safety issue: Yes ]
• Change from mid-point of study in self-reported quality of life at 60 days. [ Time Frame: 30 and 60 days ] [ Designated as safety issue: Yes ]
• Change from Baseline in self-reported quality of life at 60 days. [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
• Change from Baseline in self-reported eating behavior at 30 days. [ Time Frame: 0 and 30 days ] [ Designated as safety issue: No ]
  A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior
• Change from mid-point of study in self-reported eating behavior at 60 days [ Time Frame: 30 and 60 days ] [ Designated as safety issue: No ]
  A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior
• Change from Baseline in self-reported eating behavior at 60 days. [ Time Frame: 0 and 60 days ] [ Designated as safety issue: No ]
  A subscale of the 86-item quality of life inventory assessing 15 items related to the subjects' ability to control eating behavior
• Change from mid-point of study in Systolic and Diastolic Blood Pressure at 60 days [ Time Frame: 30 and 60 days ] [ Designated as safety issue: Yes ]
  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.
• Number of participants with adverse events [ Time Frame: up to 60 days ] [ Designated as safety issue: Yes ]
  Participants will have opportunity to report on a daily basis any adverse events experienced.

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.)

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.

• Dietary Supplement: Advantra Z
  Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine.
  Other Name: p-synephrine
• Dietary Supplement: Advantra Z + Naringin + Hesperiden
  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.
  Other Names:

  • Naringin
  • Hesperiden
• Other: Sugar pill
  Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.
  Other Name: Placebo

• Active Comparator: Advantra Z
  Proprietary ingredient for: stimulating thermogenesis, reducing weight, increasing lean muscle mass to total body mass, improving athletic performance, and suppressing appetite
  Intervention: Dietary Supplement: Advantra Z
• Active Comparator: Advantra Z + Naringin + Hesperiden
  Intervention: Dietary Supplement: Advantra Z + Naringin + Hesperiden
• Placebo Comparator: Sugar pill
  Capsule contains inert ingredient.
  Intervention: Other: Sugar pill

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