Ginger Capsules for the Chronic Treatment of Obesity

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Unknown status

CT.gov ID

NCT02742194

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Dietary Supplement: Dry extract of ginger Dietary Supplement: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in basal metabolic rate. [Baseline and 30, 60, 90, 120, 150 and 180 days]
Ginger effect in basal metabolic rate will be measured by calorimetry.
Change in body fat percentage. [Baseline and 30, 60, 90, 120, 150 and 180 days]
Ginger effect in body fat percentage will be measured by bioimpedance.

Secondary Outcome Measures

Changes in serum levels of inflammatory mediators [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.
Change in depressive symptoms. [Baseline and 30, 60, 90, 120, 150 and 180 days]
Nutritional effect in depressive symptoms will be measured by the Beck Depression Inventory.
Change in anxiety symptoms. [Baseline and 30, 60, 90, 120, 150 and 180 days]
Nutritional effect in anxiety symptoms will be measured by the Beck Anxiety Inventory.
Change in quality of life. [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.
Change in perceived stress. [Baseline and 30, 60, 90, 120, 150 and 180 days]
Nutritional effect in perceived stress will be measured by the Perceived Stress Scale.
Change in quality of diet. [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.
Changes in serum levels of neurotrophic factors [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas	Belo Horizonte	Minas Gerais	Brazil	30130-100

Sponsors and Collaborators

Federal University of Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Study Director: Adaliene VM Ferreira, PhD, Federal University of Minas Gerais
Study Chair: Nayara M Monteze, Ma, Federal University of Minas Gerais
Principal Investigator: Antônio L Teixeira, PhD, Federal University of Minas Gerais