Clinical trial NCT02742194: Ginger Capsules for the Chronic Treatment of Obesity
Official title: Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition in the Obesity Treatment and Improvement Behavioral Profile
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Keywords: ginger obesity
ginger inflammation
treatment of obesity
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-04-18
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in basal metabolic rate.
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
measure: Change in body fat percentage.
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
Secondary outcomes:
measure: Changes in serum levels of inflammatory mediators
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
measure: Change in depressive symptoms.
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
measure: Change in anxiety symptoms.
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
measure: Change in quality of life.
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
measure: Change in perceived stress.
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
measure: Change in quality of diet.
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
measure: Changes in serum levels of neurotrophic factors
timeFrame: Baseline and 30, 60, 90, 120, 150 and 180 days
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Adaliene VM Ferreira, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of Minas Gerais
name: Nayara M Monteze, Ma
role: STUDY_CHAIR
affiliation: Federal University of Minas Gerais
name: Antônio L Teixeira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.