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Thermogenic Properties of Zantrex-3 (ZANTREX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01622101
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : June 21, 2012
Sponsor:
Information provided by (Responsible Party):
AAstrup, University of Copenhagen

Brief Summary:

Background: Zantrex-3® is a popular dietary supplement for weight control, which consists of a combination of yerba mate, guarana, caffeine and damiana. The combination has previously been shown to decrease gastric emptying and its weight controlling effects may be related to increased satiety and thermogenesis.

Objective: To investigate the effect of Zantrex-3® on energy expenditure, hemodynamic factors and subjective appetite sensations.

Design: Twenty-three men (BMI: 23.9±3.2 kg/m2, mean±SD) participated in a randomized, double-blind, placebo-controlled crossover study. The Zantrex-3® compound contained 365 mg xantines (caffeine and caffeine-like stimulants), yerba mate, guarana and damiana. The thermogenic effect was measured for 3 hours post-intake. Blood pressure (BP), heart rate (HR) and appetite ratings were assessed every half hour.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Thermogenic properties of Zantrex-3® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Acute Effects of Zantrex-3 on Energy Expenditure and Appetite Sensations
Study Start Date : May 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: zantrex
The test compound was administered as tablets. The Zantrex-3® compound contained yerba maté, caffeine, guarana, damiana, green tea, kola nut, schizonepeta, piper nigrum, ginseng, maca root, and cocoa nut. The content of xantines (caffeine and caffeine-like stimulants) accounted for 365 mg per serving (2 capsules).
Dietary Supplement: Thermogenic properties of Zantrex-3®
The present study was designed as a 2-arm randomised, placebo-controlled, double-blind crossover study. Each treatment was separated by >7 d washout period. Both treatments were administered as tablets. The Zantrex-3® compound contained yerba maté, caffeine, guarana, damiana, green tea, kola nut, schizonepeta, piper nigrum, ginseng, maca root, and cocoa nut. The content of xantines (caffeine and caffeine-like stimulants) accounted for 365 mg per serving (2 capsules) or 1095 mg (6 capsules) if given as a daily dose. The placebo supplement contained rice flower and could not be distinguished from the Zantrex-3® compound with regard to colour, taste, smell or ap-pearance.

Placebo Comparator: Control
The placebo supplement contained rice flower and could not be distinguished from the Zantrex-3® compound with regard to colour, taste, smell or appearance.
Dietary Supplement: Thermogenic properties of Zantrex-3®
The present study was designed as a 2-arm randomised, placebo-controlled, double-blind crossover study. Each treatment was separated by >7 d washout period. Both treatments were administered as tablets. The Zantrex-3® compound contained yerba maté, caffeine, guarana, damiana, green tea, kola nut, schizonepeta, piper nigrum, ginseng, maca root, and cocoa nut. The content of xantines (caffeine and caffeine-like stimulants) accounted for 365 mg per serving (2 capsules) or 1095 mg (6 capsules) if given as a daily dose. The placebo supplement contained rice flower and could not be distinguished from the Zantrex-3® compound with regard to colour, taste, smell or ap-pearance.




Primary Outcome Measures :
  1. Acute 3-h changes from baseline in energy expenditure and respiratory quotient (RQ) [ Time Frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >7 days.respiratory measurements were of 3-h duration post dose ]

    Subjects underwent assessments of resting metabolic rate (RMR) and respiratory quotient (RQ) by indirect calorimetry using a ventilated hood system (Oxycon Champion, Mijnhardt B.V, Bunnick, The Nederlands).

    The respiratory measurements were of 3-h duration; from 10 a.m. to 1 p.m. Two baseline measurements (25 minutes) were performed between 9 a.m - 10 a.m. At 10 a.m the participants ingested one serving of the Zantrex-3® supplement or placebo and 25-minutes respiratory measurements were repeated 6 times over the next 3 hours (post-dose).



Secondary Outcome Measures :
  1. 3-h acute change in blood pressure (systolic and diastolic) [ Time Frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >7 days. Measurements were carried out at baseline and time 30, 60, 90, 120, 150 and 180 minutes ]
    Heart rate and blood pressure were measured using a digital blood pressure meter with an automati-cally inflating cuff of appropriate cuff size. The results were given as means of 2 to 3 consecutive measurements

  2. 3-h acute change in heart rate [ Time Frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >7 days. Measurements were carried out at baseline and time 30, 60, 90, 120, 150 and 180 minutes ]
    Heart rate and blood pressure were measured using a digital blood pressure meter with an automati-cally inflating cuff of appropriate cuff size. The results were given as means of 2 to 3 consecutive measurements

  3. Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales [ Time Frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >7 days. On each test day appetite sensations are measured prior to the test compound (time 0) and 30, 60, 90, 120, 150, 180 minutes post intake ]

    Assessment of subjective appetite sensations (visual analogue scales (VAS)) at time 0 (baseline - prior to the test meal) and at time 15, 30, 45, 60, 90, 120, 150, 180 minutes post intake.

    Measured subjective appetite sensations of hunger, satiety, prospective consumption, fullness, composite appetite score and sensory desires to something sweet, salty, rich in fat, or meat/fish.


  4. Acute 3-h changes from baseline in self-reported discomfort [ Time Frame: Measured on 2 seperate test days in a crossover design. Each test day is seperated by >7 days. On each test day the subjects were asked if they felt any physiological discomfort after ingesting the test compound ]
    The subjects were asked about physiological discomfort trought out the test days.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy,
  • BMI: 23-30 kg/m2,
  • Weight stable (within +/- 3 kg) two months prior to study inclusion,
  • Non-smoking,
  • Nonathletic (< 10 h hard physical activity), *The subjects followed a normal Danish habitual diet with rare use of hot spices

Exclusion Criteria:

  • Change in smoking status,
  • Daily or frequent use of medication,
  • Suffering from metabolic diseases,
  • Suffering from psychiatric diseases,
  • Suffering from any other clinical condition, which would make the subject unfit to participate in the study,

    • use of dietary supplements or frequent use of medication
    • blood pressure above 160/90 mmHg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622101


Locations
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Denmark
Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Arne Astrup, Professor, Dr Med Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark

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Responsible Party: AAstrup, Professor, Dr Med, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01622101    
Other Study ID Numbers: B238
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012
Keywords provided by AAstrup, University of Copenhagen:
Energy expenditure
Appetite
Bioactive herbal compounds
blood pressure
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents