Ginger Capsules for the Chronic Treatment of Obesity

Federal University of Minas Gerais

Status and phase: Unknown; Phase 2

Conditions: Obesity

Treatments: Dietary Supplement: Dry extract of ginger; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02742194

CAAE 30409114.8.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Ginger group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Dry extract of ginger