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Completed

NCT Number: NCT01622101

Thermogenic Properties of Zantrex-3

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark

Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Thermogenic properties of Zantrex-3®

Dietary Supplement

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Acute Effects of Zantrex-3 on Energy Expenditure and Appetite Sensations

Acronym: ZANTREX

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jun 18, 2012
Registry last updated
Jun 21, 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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