Thermogenic Effect of Ginger

Double-blind Placebo-controlled Clinical Trial of Thermogenic Effect of Ginger (Zingiber Officinale) in Eutrophic Women

The main objective of the study is to evaluate the thermogenic effect of ginger.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Extract of ginger; Other: Placebo (Cellulose)

Detailed Description

Healthy and eutrophic women will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose), along with a standardized breakfast, with a minimum seven days washout period.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Hospital das Clínicas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females;
• Aged between 18 and 60 years old;
• Body mass index between 18.5 and 24.9 kg/m²;
• Agree to sign the informed consent.

Exclusion Criteria:

• Any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease);
• Previous operation for weight loss;
• Medications known to affect total energy expenditure;
• Pregnancy and breast-feeding;
• Smoking;
• Alcohol use (>2 doses/day).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extract of ginger; Healthy and eutrophic women will receive two capsules of 200 mg of ginger extract (5% gingerols) to be taken along with a standardized breakfast.	Other: Extract of ginger; The volunteers will receive two capsules containing 200mg of extract of ginger with 5% of gingerols (20 mg). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.
Placebo Comparator: Cellulose; Healthy and eutrophic women will receive two capsules of 200 mg of placebo (cellulose) to be taken along with a standardized breakfast.	Other: Placebo (Cellulose); The volunteers will receive two capsules containing cellulose (placebo). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postprandial energy expenditure	Energy expenditure will be assessed by indirect calorimetry	Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oxygen consumption	Oxygen consumption will be assessed by indirect calorimetry	Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in blood pressure	Blood pressure will be assessed using digital sphygmomanometer	Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in axillary temperature	Axillary temperature will be assessed using a digital thermometer	Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in metabolic profile	Total cholesterol	Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Change in heart rate	Heart rate will be assessed using digital sphygmomanometer	Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial
Change in metabolic profile	Glucose levels	Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial
Change in metabolic profile	HDL-cholesterol	Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Study Chair: Gabriela BP Fagundes, Federal University of Minas Gerais

Publications and helpful links

General Publications

• Fagundes GBP, Rodrigues AMDS, Martins LB, Monteze NM, Correia MITD, Teixeira AL, Ferreira AVM. Acute effects of dry extract of ginger on energy expenditure in eutrophic women: A randomized clinical trial. Clin Nutr ESPEN. 2021 Feb;41:168-174. doi: 10.1016/j.clnesp.2020.10.001. Epub 2020 Nov 9.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2017
• Primary Completion (Actual): June 14, 2017
• Study Completion (Actual): June 14, 2017

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 19, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Energy Expenditure; Thermic Effect of Food; Ginger
• Other Study ID Numbers: UFMG 30409114.8.0000.5149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No