Double-blind Placebo-controlled Clinical Trial of Ginger (Zingiber Officinale) Addition in the Obesity Treatment and Improvement Behavioral Profile
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Change in body fat percentage.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-60 years old;
- •Body mass index 25-35 kg/m².
排除标准
- •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.
结局指标
主要结局
Change in body fat percentage.
时间窗: Baseline and 30, 60, 90, 120, 150 and 180 days
Ginger effect in body fat percentage will be measured by bioimpedance.
Change in basal metabolic rate.
时间窗: Baseline and 30, 60, 90, 120, 150 and 180 days
Ginger effect in basal metabolic rate will be measured by calorimetry.
次要结局
- Changes in serum levels of inflammatory mediators(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 quality of diet.(Baseline and 30, 60, 90, 120, 150 and 180 days)
- Change in anxiety symptoms.(Baseline and 30, 60, 90, 120, 150 and 180 days)
- Changes in serum levels of neurotrophic factors(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 perceived stress.(Baseline and 30, 60, 90, 120, 150 and 180 days)
研究者
Antonio L Teixeira Jr
MD, PhD
Federal University of Minas Gerais