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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.)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advantra Z | Active Comparator | Proprietary ingredient for: stimulating thermogenesis, reducing weight, increasing lean muscle mass to total body mass, improving athletic performance, and suppressing appetite |
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| Advantra Z + Naringin + Hesperiden | Active Comparator |
| |
| Sugar pill | Placebo Comparator | Capsule contains inert ingredient. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advantra Z | Dietary Supplement | Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilbert R Kaats, PhD FACN | Integrative Health Technologies, Inc. | Principal Investigator |
| Harry G Preuss, MD MACN | Georgetown University Medical Center, Departments of Biochemistry, Medicine and Pathology | Study Chair |
| Sidney J Stohs, PhD | Dean Emeritus, Creighton University Health Sciences Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Health Technologies, Inc. | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21537493 | Background | Stohs SJ, Preuss HG, Keith SC, Keith PL, Miller H, Kaats GR. Effects of p-synephrine alone and in combination with selected bioflavonoids on resting metabolism, blood pressure, heart rate and self-reported mood changes. Int J Med Sci. 2011 Apr 28;8(4):295-301. doi: 10.7150/ijms.8.295. |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005274 | naringin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Advantra Z + Naringin + Hesperiden | Dietary Supplement | 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. |
|
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| Sugar pill | Other | Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals. |
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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 |