Ginger Capsules for the Chronic Treatment of Obesity

Study Overview
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Brief Summary
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Regarding its complex pathogenesis and clinic-epidemiological meaning, different strategies are needed for the treatment of obesity. Ginger is the rhizome of a plant with thermogenic and anti-inflammatory effects, and may be a promising alternative as add-on strategy in the treatment for obesity. The primary objective of the current study is to assess whether consumption of ginger as an add-on strategy to restrictive diet is effective to reduce fat body percentage, increase basal metabolic rate and improve loss weight. The secondary objectives are: to assess the effect of nutritional intervention in quality of diet and weight loss. to evaluate the effect of ginger on behavioral symptoms and peripheral biomarkers in overweight subjects.

Detailed Description
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Overweight individuals will be interviewed at baseline and after 30, 60, 90, 120, 150 and 180 days from baseline. The following measures will be assessed: body composition (fat body% and free fat body%), anthropometric measures (height, weight, body mass index, waist circumference and abdominal circumference), blood pressure, basal metabolic rate, behavioral symptoms, binge eating (binge eating scale) and peripheral biomarkers. Behavioral symptoms will be assessed using the following self-reported questionnaires: Beck Depression Inventory (depression symptoms), Beck Anxiety Inventory (anxiety symptoms), Medical Outcomes Study 36 - Item Short - Form Health Survey (quality of life) and Perceived Stress Scale (stress). Enrolled participants will receive restrictive diet calculated on individual requirements aiming at the loss from two to four kilogram per month in addition to capsules of ginger or placebo, as follows: Group 1 will receive vials containing 90 capsules of 200mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months in addition to restrictive diet. Group 2 will receive vials containing 90 capsules of 200mg of placebo (cellulose) to be taken three times a day for six months in addition to restrictive diet.

Official Title
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Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition in the Obesity Treatment and Improvement Behavioral Profile

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Dry extract of ginger
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-60 years old; Body mass index 25-35 kg/m². Exclusion Criteria: Pregnant or lactating women; Abuse of alcohol or drugs; Hypersensitivity to ginger; Other endocrine disease; Women in use of insulin or anti-inflammatory and antidepressants drugs.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Conventional treatment (restrictive diet) plus capsules of 200 mg of cellulose (placebo) to be taken three times a day for six months. | Dietary Supplement: Placebo<br>* Restrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months.<br>|
| Experimental: Ginger group<br>Conventional treatment (restrictive diet) plus capsules of 200 mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months. | Dietary Supplement: Dry extract of ginger<br>* Restrictive diet plus three capsules of 200 mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in basal metabolic rate. | Ginger effect in basal metabolic rate will be measured by calorimetry. | Baseline and 30, 60, 90, 120, 150 and 180 days | 
| Change in body fat percentage. | Ginger effect in body fat percentage will be measured by bioimpedance. | Baseline and 30, 60, 90, 120, 150 and 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum levels of inflammatory mediators | Nutritional effect in the levels of Interleukin-1, interleukin-6 and interleukin-10, tumor necrosis factor and protein C reactive. | Baseline and 30, 60, 90, 120, 150 and 180 days | 
| Change in depressive symptoms. | Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory. | Baseline and 30, 60, 90, 120, 150 and 180 days | 
| Change in anxiety symptoms. | Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory. | Baseline and 30, 60, 90, 120, 150 and 180 days | 
| Change in quality of life. | Nutritional effect in quality of life will be measured by Medical Outcomes Study 36 - Item Short - Form Health Survey. | Baseline and 30, 60, 90, 120, 150 and 180 days | 
| Change in perceived stress. | Nutritional effect in perceived stress will be measured by the Perceived Stress Scale. | Baseline and 30, 60, 90, 120, 150 and 180 days | 
| Change in quality of diet. | Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10. | Baseline and 30, 60, 90, 120, 150 and 180 days | 
| Changes in serum levels of neurotrophic factors | Nutritional effect in the serum levels of Brain-derived neurotrophic factor, glial-derived neurotrophic factor and neurotrophin-3 and neurotrophin 4/5. | Baseline and 30, 60, 90, 120, 150 and 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ginger obesity, ginger inflammation, treatment of obesity