Ginger Capsules for the Chronic Treatment of Obesity

NCT ID: NCT02742194

Last Updated: 2016-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-11-30

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Conventional treatment (restrictive diet) plus capsules of 200 mg of cellulose (placebo) to be taken three times a day for six months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Restrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months.

Ginger group

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.

Group Type: EXPERIMENTAL

Dry extract of ginger

Intervention Type: 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.

Interventions

Dry 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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Restrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Antonio L Teixeira Jr

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adaliene VM Ferreira, PhD

Role: STUDY_DIRECTOR

Federal University of Minas Gerais

Nayara M Monteze, Ma

Role: STUDY_CHAIR

Federal University of Minas Gerais

Antônio L Teixeira, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

Hospital das Clínicas

Belo Horizonte, Minas Gerais, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Antônio L Teixeira, PhD

Role: CONTACT

altexr@gmail.com

+55 31 3409-8073

Antônio L Teixeira, PhD

Role: CONTACT

altexr@gmail.com

+553134098073

Facility Contacts

Antônio L Teixeira, PhD

Role: primary

altexr@gmail.com

+55 31 3409-8073

References

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.

Reference Type: BACKGROUND

PMID: 23197842 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24149559 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16194058 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23021155 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24615565 (View on PubMed)

Other Identifiers

CAAE 30409114.8.0000.5149

Identifier Type: -

Identifier Source: org_study_id