Obesity
Conditions
Keywords
ginger obesity, ginger inflammation, treatment of obesity
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.
Interventions
DIETARY_SUPPLEMENTDry extract of ginger
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.
DIETARY_SUPPLEMENTPlacebo
Restrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
| 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. |
Countries
Brazil
Contacts
Primary ContactAntônio L Teixeira, PhD
Backup ContactAntônio L Teixeira, PhD
Outcome results
None listed