Clinical trial NCT01423019: A Comparative Effectiveness Study Evaluating the Effects of Thermogenic Supplements on Body Composition
Official title: A Comparative Effectiveness Study Evaluating the Effects of Two Thermogenic Supplements on Body Composition Using a Double-Blinded Placebo-Controlled Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
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
Lead sponsor: Integrative Health Technologies, Inc.
Sponsor class: NETWORK
First posted: 2011-08-25
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA)
timeFrame: 0 and 60 days
Secondary outcomes:
measure: 43-item blood chemistry panel
timeFrame: 0 and 60 days
measure: Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days
timeFrame: 0 and 30 days
measure: Change from Baseline in Resting Heart Rate at 30 days
timeFrame: 0 and 30 days
measure: Change from midpoint of study in Resting Heart Rate at 60 days
timeFrame: 30 and 60 days
measure: Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days
timeFrame: 0 and 60 days
measure: Change from Baseline in Resting Heart Rate at 60 days
timeFrame: 0 and 60 days
measure: Change from Baseline in self-reported quality of life at 30 days.
timeFrame: 0 and 30 days
measure: Change from mid-point of study in self-reported quality of life at 60 days.
timeFrame: 30 and 60 days
measure: Change from Baseline in self-reported quality of life at 60 days.
timeFrame: 0 and 60 days
measure: Change from Baseline in self-reported eating behavior at 30 days.
timeFrame: 0 and 30 days
measure: Change from mid-point of study in self-reported eating behavior at 60 days
timeFrame: 30 and 60 days
measure: Change from Baseline in self-reported eating behavior at 60 days.
timeFrame: 0 and 60 days
measure: Change from mid-point of study in Systolic and Diastolic Blood Pressure at 60 days
timeFrame: 30 and 60 days
measure: Number of participants with adverse events
timeFrame: up to 60 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Integrative Health Technologies, Inc.
state: Texas
Study officials:
affiliation: Integrative Health Technologies, Inc.
name: Gilbert R Kaats, PhD FACN
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University Medical Center, Departments of Biochemistry, Medicine and Pathology
name: Harry G Preuss, MD MACN
role: STUDY_CHAIR
affiliation: Dean Emeritus, Creighton University Health Sciences Center
name: Sidney J Stohs, PhD
role: STUDY_DIRECTOR
References:
citation: 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.