Thermogenic Properties of Zantrex-3

NCT01622101 | Completed

• 1 other identifier: B238
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Energy expenditure; Appetite; Bioactive herbal compounds; blood pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 3-h acute change in blood pressure (systolic and diastolic)

  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

  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

  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

  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

Study Arms (2)

zantrex

EXPERIMENTAL

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®

Control

PLACEBO COMPARATOR

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®

Interventions

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.

Control; zantrex

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy,
• BMI: 23-30 kg/m2,
• Non-smoking,
• Nonathletic (\< 10 h hard physical activity), \*The subjects followed a normal Danish habitual diet with rare use of hot spices

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

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

Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Arne Astrup, Professor, Dr Med

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Dr Med

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: June 18, 2012
• Study Start: May 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

DK (1)