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

January 20, 2012 updated by: Gilbert R Kaats, Integrative Health Technologies, Inc.

A Comparative Effectiveness Study Evaluating the Effects of Two Thermogenic Supplements on Body Composition Using a Double-Blinded Placebo-Controlled Protocol

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.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • Integrative Health Technologies, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Advantra Z
Proprietary ingredient for: stimulating thermogenesis, reducing weight, increasing lean muscle mass to total body mass, improving athletic performance, and suppressing appetite
Dietary supplement: Advantra 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.
Other Names:
  • p-synephrine
Active Comparator: Advantra Z + Naringin + Hesperiden
Dietary supplement: Advantra 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.
Other Names:
  • Naringin
  • Hesperiden
Placebo Comparator: Sugar pill
Capsule contains inert ingredient.
Other: Sugar pill
Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Composition (fat, fat-free mass and bone mineral density) as measured by Dual Energy X-ray Absorptiometry (DXA)
Time Frame: 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.
0 and 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
43-item blood chemistry panel
Time Frame: 0 and 60 days
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
Time Frame: 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.
0 and 30 days
Change from Baseline in Resting Heart Rate at 30 days
Time Frame: 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.
0 and 30 days
Change from midpoint of study in Resting Heart Rate at 60 days
Time Frame: 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.
30 and 60 days
Change from Baseline in Systolic and Diastolic Blood Pressure at 60 days
Time Frame: 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.
0 and 60 days
Change from Baseline in Resting Heart Rate at 60 days
Time Frame: 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.
0 and 60 days
Change from Baseline in self-reported quality of life at 30 days.
Time Frame: 0 and 30 days
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
30 and 60 days
Change from Baseline in self-reported quality of life at 60 days.
Time Frame: 0 and 60 days
0 and 60 days
Change from Baseline in self-reported eating behavior at 30 days.
Time Frame: 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
0 and 30 days
Change from mid-point of study in self-reported eating behavior at 60 days
Time Frame: 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
30 and 60 days
Change from Baseline in self-reported eating behavior at 60 days.
Time Frame: 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
0 and 60 days
Change from mid-point of study in Systolic and Diastolic Blood Pressure at 60 days
Time Frame: 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.
30 and 60 days
Number of participants with adverse events
Time Frame: up to 60 days
Participants will have opportunity to report on a daily basis any adverse events experienced.
up to 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrative Health Technologies, Inc.

Investigators

  • Principal Investigator: Gilbert R Kaats, PhD FACN, Integrative Health Technologies, Inc.
  • Study Chair: Harry G Preuss, MD MACN, Georgetown University Medical Center, Departments of Biochemistry, Medicine and Pathology
  • Study Director: Sidney J Stohs, PhD, Dean Emeritus, Creighton University Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 5, 2011

First Submitted That Met QC Criteria

August 23, 2011

First Posted (Estimate)

August 25, 2011

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 20, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nutratech - 60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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