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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Conventional treatment (restrictive diet) plus capsules of 200 mg of cellulose (placebo) to be taken three times a day for six months. |
|
| Ginger group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry extract of ginger | Dietary Supplement | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antônio L Teixeira, PhD | Contact | +55 31 3409-8073 | altexr@gmail.com | |
| Antônio L Teixeira, PhD | Contact | +553134098073 | altexr@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adaliene VM Ferreira, PhD | Federal University of Minas Gerais | Study Director |
| Nayara M Monteze, Ma | Federal University of Minas Gerais | Study Chair |
| Antônio L Teixeira, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas | Recruiting | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23197842 | Background | van Reedt Dortland AK, Giltay EJ, van Veen T, Zitman FG, Penninx BW. Longitudinal relationship of depressive and anxiety symptoms with dyslipidemia and abdominal obesity. Psychosom Med. 2013 Jan;75(1):83-9. doi: 10.1097/PSY.0b013e318274d30f. Epub 2012 Nov 28. | |
| 24149559 | Background | Atashak S, Peeri M, Azarbayjani MA, Stannard SR, Haghighi MM. Obesity-related cardiovascular risk factors after long- term resistance training and ginger supplementation. J Sports Sci Med. 2011 Dec 1;10(4):685-91. eCollection 2011. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Restrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months. |
|
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 |
| Federal University of Minas Gerais |
| Principal Investigator |
| 16194058 | Background | Chrubasik S, Pittler MH, Roufogalis BD. Zingiberis rhizoma: a comprehensive review on the ginger effect and efficacy profiles. Phytomedicine. 2005 Sep;12(9):684-701. doi: 10.1016/j.phymed.2004.07.009. |
| 23021155 | Background | Gregersen NT, Belza A, Jensen MG, Ritz C, Bitz C, Hels O, Frandsen E, Mela DJ, Astrup A. Acute effects of mustard, horseradish, black pepper and ginger on energy expenditure, appetite, ad libitum energy intake and energy balance in human subjects. Br J Nutr. 2013 Feb 14;109(3):556-63. doi: 10.1017/S0007114512001201. Epub 2012 Jul 5. |
| 24615565 | Background | Saravanan G, Ponmurugan P, Deepa MA, Senthilkumar B. Anti-obesity action of gingerol: effect on lipid profile, insulin, leptin, amylase and lipase in male obese rats induced by a high-fat diet. J Sci Food Agric. 2014 Nov;94(14):2972-7. doi: 10.1002/jsfa.6642. Epub 2014 Apr 7. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |