Investigations of Botanicals on Food Intake, Satiety, Weight Loss, and Oxidative Stress
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Food Intake (kcal/day)
研究概览
简要总结
Despite widespread efforts to improve the treatment of obesity, only limited progress has been made. Calorie restriction (CR) has consistently been shown to produce weight loss, as well as delay the onset of age-related diseases, in numerous species. Most overweight individuals, however, are unable to sustain CR induced weight losses, possibly due to internal feedback systems that signal the body to increase food intake or decrease energy expenditure in response to weight loss. Novel treatment approaches are thus urgently needed that can assist overweight individuals in adhering to a CR regimen over the long-term.
Botanicals represent an important and underexplored source of potential new therapies that may facilitate CR. In particular, one promising botanical that may reduce food intake and body weight by affecting neuroendocrine pathways related to satiety is Garcinia Cambogia (Garcinia Cambogia Desr.)-derived (-)-hydroxycitric acid. This compound has been found to facilitate weight loss in a number of studies. To date, few studies have directly tested the effect that this botanical on food intake in humans, its mechanism of action, or its effect on oxidative stress levels; thus rigorous scientific studies on this compounds need to be conducted. A double-blind, placebo-controlled crossover study will be conducted to explore the role that two different doses of this botanical compound have on food intake, satiety, weight loss, and oxidative stress levels. It is hypothesized that compared to placebo, both doses of Garcinia Cambogia (hydroxycitric acid) will reduce food intake, increase satiety, decrease weight, and reduce oxidative stress levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy individual with normal blood chemistries and platelet counts who has not been diagnosed with diabetes, cardiovascular illness, or other chronic diseases
- •50 to 70 years of age
- •body mass index between 25 and 39.9 kg/m2
- •for females, post-menopausal (i.e., no menstrual cycle for > one year).
排除标准
- •Potential participants will be excluded if their scores on the dietary restraint, disinhibition, and perceived hunger scales of the Eating Inventory are high (>14)
- •Participants who report smoking cigarettes will be excluded because of the effects of nicotine upon taste and appetite
- •Participants who have a diagnosable eating disorder will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data
- •Participants will be excluded if they are taking anti-depressant medications, anti-psychotic medications, or any medications, botanicals, or other products that may potentially influence appetite, hunger, and/or satiety
- •Participants will be excluded if they report alcohol or substance abuse within 6 months or consumption of >14 alcohol drinks/week
- •Participants will also be excluded if they report any allergies to the foods used in the study
- •Volunteers will also be ineligible if they have significant medical conditions (e.g., history or clinical manifestation of cardiovascular disease, diabetes, cholelithiasis, liver or renal disease, or cancer)
- •abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels or hemoglobin and hematocrit below the lower limit of normal)
- •psychiatric or behavioral problems (e.g., eating disorders or a history of drug and alcohol abuse)
- •concomitant medications (e.g., steroids)
- •Volunteers will be screened out if they are unwilling or unable to adhere to different supplement regimens over an eight month period.
结局指标
主要结局
Food Intake (kcal/day)
时间窗: Measured every six weeks over a 30 week period
Participant food intake will be measured at each meal of every test meal day, once at breakfast, lunch, and dinner. Test meal days occur at the baseline visit, after six weeks of the the first condition (week 6), after the following six week wash out period (week 12), after the following six weeks of the second condition (week 18), after the following six week wash out period (week 24), and after the six weeks of the third and final condition (week 30). Conditions include both the doses of the treatment and the placebo dose as well.
次要结局
- Satiety(Measured every six weeks over a 30 week period)
- Body Weight(Every six weeks over a 30 week period)
- Oxidative Stress(Every Six weeks for 30 weeks)