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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
75
Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine.
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.
Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.
Integrative Health Technologies, Inc.
San Antonio, Texas, United States
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.
Time frame: 0 and 60 days
43-item blood chemistry panel
43 chemistries including Lipids, CBC, Metabolic panel, TSH, and Cardio CrP
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 0 and 60 days
Change from Baseline in self-reported quality of life at 30 days.
Time frame: 0 and 30 days
Change from mid-point of study in self-reported quality of life at 60 days.
Time frame: 30 and 60 days
Change from Baseline in self-reported quality of life at 60 days.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 30 and 60 days
Number of participants with adverse events
Participants will have opportunity to report on a daily basis any adverse events experienced.
Time frame: up to 60 days