Weight Loss
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTAdvantra 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.
DIETARY_SUPPLEMENTAdvantra 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.
OTHERSugar pill
Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.
Sponsors
Integrative Health Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA) | 0 and 60 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 43-item blood chemistry panel | 0 and 60 days | 43 chemistries including Lipids, CBC, Metabolic panel, TSH, and Cardio CrP |
| Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days | 0 and 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. |
| Change from Baseline in Resting Heart Rate at 30 days | 0 and 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. |
| Change from midpoint of study in Resting Heart Rate at 60 days | 30 and 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. |
| Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days | 0 and 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. |
| Change from Baseline in Resting Heart Rate at 60 days | 0 and 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. |
| Change from mid-point of study in self-reported eating behavior at 60 days | 30 and 60 days | 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 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. | 0 and 30 days | 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. | 0 and 60 days | 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 | 30 and 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. |
| Number of participants with adverse events | up to 60 days | Participants will have opportunity to report on a daily basis any adverse events experienced. |
| Change from Baseline in self-reported quality of life at 30 days. | 0 and 30 days | — |
Countries
United States
Outcome results
None listed