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

Not Applicable

Completed

• Conditions: Weight Loss

• Registration Number: NCT01423019
• Lead Sponsor: Integrative Health Technologies, Inc.

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.

Study Timeline

• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-25
• Study Start: 2011-10
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-20
• Last Update Posted: 2012-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.	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 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 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.

Trial Locations

Locations (1)

Integrative Health Technologies, Inc.; 🇺🇸 San Antonio, Texas, United States