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Completed

NCT Number: NCT01423019

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

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.)

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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Integrative Health Technologies, Inc.

San Antonio, Texas, 78209, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: p-synephrine

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.

Other names: Naringin, Hesperiden

Sugar Pill

Other

Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 43-item blood chemistry panel

    Time frame: 0 and 60 days

    43 chemistries including Lipids, CBC, Metabolic panel, TSH, and Cardio CrP

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Change from Baseline in self-reported quality of life at 30 days.

    Time frame: 0 and 30 days

  8. Change from mid-point of study in self-reported quality of life at 60 days.

    Time frame: 30 and 60 days

  9. Change from Baseline in self-reported quality of life at 60 days.

    Time frame: 0 and 60 days

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

Integrative Health Technologies, Inc.

Network

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2011
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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