Thermogenic Effect of Ginger

Study Overview
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Brief Summary
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The main objective of the study is to evaluate the thermogenic effect of ginger.

Detailed Description
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Extract of ginger
* Other: Placebo (Cellulose)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extract of ginger<br>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<br>* 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.<br>|
| Placebo Comparator: Cellulose<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ginger, Thermic Effect of Food, Energy Expenditure