A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Change From Baseline in Body Weight at 48 Weeks
研究概览
简要总结
This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
详细描述
Overweight and obesity are increasingly prevalent in the veteran population as well as the general public. For patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions. The purpose of this study is to compare the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (Atkins) with a combination of a low-fat diet and Orlistat. The outcomes examined over a 48 week duration will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive weight loss interventions.
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
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must have a VA medical center primary care provider;
- •Failed first line diet and exercise recommendations;
- •In stable health by screening physical and lab tests;
- •Agrees to make regular visits per study protocol;
- •Has access to telephone;
- •Body mass index (BMI) > or = 27 with obesity-related illness OR BMI > or = 30 with no risk factors;
- •No contraindications to Orlistat;
- •Not pregnant or breast-feeding;
- •No serious mental health illness such as dementia or schizophrenia;
- •No use of a weight loss therapy in the month prior to screening.
排除标准
- •No VAMC primary care provider
- •Unable to attend regular study visits
- •No access to telephone
- •BMI < 27
- •Contraindications to Orlistat
- •Pregnancy, breast feeding or planning to become pregnant
- •Unstable mental health illness
- •Use of a weight loss therapy in the month prior to screening
研究组 & 干预措施
Low Carbohydrate Ketogenic Diet
Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
干预措施: Low carbohydrate ketogenic diet (Behavioral)
Low-Fat Diet plus Orlistat
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.
干预措施: Orlistat (Drug)
Low-Fat Diet plus Orlistat
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.
干预措施: Low-fat diet (Behavioral)
结局指标
主要结局
Change From Baseline in Body Weight at 48 Weeks
时间窗: baseline and 48 weeks
Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.
次要结局
- Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks(baseline and 48 weeks)
- Change From Baseline in Blood Sugar at 48 Weeks(Baseline and 48 weeks)