Thermogenic Properties of Zantrex-3

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Thermogenic properties of Zantrex-3®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: zantrex<br>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®<br>* 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.<br>|
| Placebo Comparator: Control<br>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®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute 3-h changes from baseline in energy expenditure and respiratory quotient (RQ) | 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). | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-h acute change in blood pressure (systolic and diastolic) | 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 | 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 | 
| 3-h acute change in heart rate | 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 | 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 | 
| Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales | 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. | 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 | 
| Acute 3-h changes from baseline in self-reported discomfort | The subjects were asked about physiological discomfort trought out the test days. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy expenditure, Appetite, Bioactive herbal compounds, blood pressure