Ginger Capsules for the Chronic Treatment of Obesity

April 13, 2016 updated by: Antonio L Teixeira Jr, Federal University of Minas Gerais

Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition in the Obesity Treatment and Improvement Behavioral Profile

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Antônio L Teixeira, PhD
  • Phone Number: +553134098073
  • Email: altexr@gmail.com

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Recruiting
        • Hospital das Clínicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
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
Restrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months.
EXPERIMENTAL: 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.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in basal metabolic rate.
Time Frame: Baseline and 30, 60, 90, 120, 150 and 180 days
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.
Time Frame: Baseline and 30, 60, 90, 120, 150 and 180 days
Ginger effect in body fat percentage will be measured by bioimpedance.
Baseline and 30, 60, 90, 120, 150 and 180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum levels of inflammatory mediators
Time Frame: 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.
Baseline and 30, 60, 90, 120, 150 and 180 days
Change in depressive symptoms.
Time Frame: Baseline and 30, 60, 90, 120, 150 and 180 days
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.
Time Frame: Baseline and 30, 60, 90, 120, 150 and 180 days
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.
Time Frame: 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.
Baseline and 30, 60, 90, 120, 150 and 180 days
Change in perceived stress.
Time Frame: Baseline and 30, 60, 90, 120, 150 and 180 days
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.
Time Frame: 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.
Baseline and 30, 60, 90, 120, 150 and 180 days
Changes in serum levels of neurotrophic factors
Time Frame: 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.
Baseline and 30, 60, 90, 120, 150 and 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Study Chair: Nayara M Monteze, Ma, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (ESTIMATE)

April 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 30409114.8.0000.5149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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