Ginger Capsules for the Chronic Treatment of Obesity

NCT02742194 | Unknown Phase 2 DMC

• 1 other identifier: CAAE 30409114.8.0000.5149
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

ginger obesity; ginger inflammation; treatment of obesity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Changes in serum levels of inflammatory mediators

  Baseline and 30, 60, 90, 120, 150 and 180 days

• Change in depressive symptoms.

  Baseline and 30, 60, 90, 120, 150 and 180 days

• Change in anxiety symptoms.

  Baseline and 30, 60, 90, 120, 150 and 180 days

• Change in quality of life.

  Baseline and 30, 60, 90, 120, 150 and 180 days

• Change in perceived stress.

  Baseline and 30, 60, 90, 120, 150 and 180 days

Study Arms (2)

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.

Dietary Supplement: Placebo

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.

Dietary Supplement: Dry extract of ginger

Interventions

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.

Ginger group

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-60 years old;
• Body mass index 25-35 kg/m².

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Hospital das Clínicas

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

Related Publications (5)

• 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.

  PMID: 23197842 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.

  PMID: 24149559 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.

  PMID: 16194058 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.

  PMID: 23021155 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.

  PMID: 24615565 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antônio L Teixeira, PhD

CONTACT

+55 31 3409-8073; altexr@gmail.com

Antônio L Teixeira, PhD

CONTACT

+553134098073; altexr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: April 18, 2016
• Study Start: August 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: April 18, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)