Ginger Capsules for the Chronic Treatment of Obesity
- Conditions
- Obesity
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Dry extract of ginger
- Registration Number
- NCT02742194
- Lead Sponsor
- Federal University of Minas Gerais
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 84
- Women aged 18-60 years old;
- Body mass index 25-35 kg/m².
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Conventional treatment (restrictive diet) plus capsules of 200 mg of cellulose (placebo) to be taken three times a day for six months. Ginger group Dry extract of ginger 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.
- Primary Outcome Measures
Name Time Method Change in body fat percentage. Baseline and 30, 60, 90, 120, 150 and 180 days Ginger effect in body fat percentage will be measured by bioimpedance.
Change in basal metabolic rate. Baseline and 30, 60, 90, 120, 150 and 180 days Ginger effect in basal metabolic rate will be measured by calorimetry.
- Secondary Outcome Measures
Name Time Method Change in quality of life. Baseline and 30, 60, 90, 120, 150 and 180 days Nutritional effect in quality of life will be measured by Medical Outcomes Study 36 - Item Short - Form Health Survey.
Changes in serum levels of inflammatory mediators Baseline and 30, 60, 90, 120, 150 and 180 days Nutritional effect in the levels of Interleukin-1, interleukin-6 and interleukin-10, tumor necrosis factor and protein C reactive.
Change in quality of diet. Baseline and 30, 60, 90, 120, 150 and 180 days Nutritional effect in quality of diet will be measured by the Healthy Eating Index-10.
Change in anxiety symptoms. Baseline and 30, 60, 90, 120, 150 and 180 days Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory.
Changes in serum levels of neurotrophic factors Baseline and 30, 60, 90, 120, 150 and 180 days Nutritional effect in the serum levels of Brain-derived neurotrophic factor, glial-derived neurotrophic factor and neurotrophin-3 and neurotrophin 4/5.
Change in depressive symptoms. Baseline and 30, 60, 90, 120, 150 and 180 days Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory.
Change in perceived stress. Baseline and 30, 60, 90, 120, 150 and 180 days Nutritional effect in perceived stress will be measured by the Perceived Stress Scale.
Trial Locations
- Locations (1)
Hospital das Clínicas
🇧🇷Belo Horizonte, Minas Gerais, Brazil