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Completed

NCT Number: NCT03089593

Thermogenic Effect of Ginger

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas

Belo Horizonte, Minas Gerais, 30130-100, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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).

Treatment and study plan

Extract of ginger

Other

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 (Cellulose)

Other

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.

Primary outcomes

  1. Change in postprandial energy expenditure

    Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial

    Energy expenditure will be assessed by indirect calorimetry

Secondary outcomes

  1. Change in oxygen consumption

    Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial

    Oxygen consumption will be assessed by indirect calorimetry

  2. Change in blood pressure

    Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial

    Blood pressure will be assessed using digital sphygmomanometer

  3. Change in axillary temperature

    Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial

    Axillary temperature will be assessed using a digital thermometer

  4. Change in metabolic profile

    Time frame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial

    Total cholesterol

  5. Change in heart rate

    Time frame: Baseline and thereafter at 30, 60, 120, 180 and 240 minutes postprandial

    Heart rate will be assessed using digital sphygmomanometer

  6. Change in metabolic profile

    Time frame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial

    Glucose levels

  7. Change in metabolic profile

    Time frame: Baseline and thereafter at 30, 60, 120 and 240 minutes postprandial

    HDL-cholesterol

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2017
Registry last updated
Jun 21, 2017

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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