Clinical trial NCT01622101: Thermogenic Properties of Zantrex-3
Official title: Acute Effects of Zantrex-3 on Energy Expenditure and Appetite Sensations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Energy expenditure
Appetite
Bioactive herbal compounds
blood pressure
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Acute 3-h changes from baseline in energy expenditure and respiratory quotient (RQ)
timeFrame: 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 outcomes:
measure: 3-h acute change in blood pressure (systolic and diastolic)
timeFrame: 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
measure: 3-h acute change in heart rate
timeFrame: 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
measure: Acute 3-h changes from baseline in subjective appetite sensations using visual analogue scales
timeFrame: 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
measure: Acute 3-h changes from baseline in self-reported discomfort
timeFrame: 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
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
Study officials:
affiliation: Department of Human Nutrition, Faculty of Science, University of Copenhagen, Denmark
name: Arne Astrup, Professor, Dr Med
role: PRINCIPAL_INVESTIGATOR
References: