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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilbert R Kaats, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01423019
First received: July 5, 2011
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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.)


Condition Intervention
Weight Loss
Dietary Supplement: Advantra Z
Dietary Supplement: Advantra Z + Naringin + Hesperiden
Other: Sugar pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: A Comparative Effectiveness Study Evaluating the Effects of Two Thermogenic Supplements on Body Composition Using a Double-Blinded Placebo-Controlled Protocol

Resource links provided by NLM:


Further study details as provided by Integrative Health Technologies, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 43-item blood chemistry panel [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
    43 chemistries including Lipids, CBC, Metabolic panel, TSH, and Cardio CrP

  • Change from Baseline in Systolic and Diastolic Blood Pressure at 30 days [ Time Frame: 0 and 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0 and 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 and 60 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 0 and 30 days ] [ Designated as safety issue: Yes ]
  • Change from mid-point of study in self-reported quality of life at 60 days. [ Time Frame: 30 and 60 days ] [ Designated as safety issue: Yes ]
  • Change from Baseline in self-reported quality of life at 60 days. [ Time Frame: 0 and 60 days ] [ Designated as safety issue: Yes ]
  • Change from Baseline in self-reported eating behavior at 30 days. [ Time Frame: 0 and 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 and 60 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: 0 and 60 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 and 60 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: up to 60 days ] [ Designated as safety issue: Yes ]
    Participants will have opportunity to report on a daily basis any adverse events experienced.


Estimated Enrollment: 75
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423019

Locations
United States, Texas
Integrative Health Technologies, Inc.
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Gilbert R Kaats, Dr. Gilbert R. Kaats, PhD, Integrative Health Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01423019     History of Changes
Other Study ID Numbers: Nutratech - 60
Study First Received: July 5, 2011
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Integrative Health Technologies, Inc.:
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

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Synephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Nasal Decongestants
Respiratory System Agents

ClinicalTrials.gov processed this record on July 29, 2014