Ketogenic Diets for Weight Loss Maintenance: Impact on Energy Expenditure and Appetite in Individuals With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline total energy expenditure
研究概览
简要总结
The goal of this clinical trial is to investigate whether a Ketogenic Diet (KD) can increase Total Energy Expenditure (TEE), while benefiting appetite, during weight loss maintenance in reduced-obese individuals.
详细描述
The total duration of the intervention will be 10 weeks. Participants will first undergo 4 weeks of a low-energy diet (LED), aiming to induce a minimum of 5% weight loss (weight loss phase). Those who achieve at least a 5% weight loss will then be randomized (1:1) to a 6-week weight loss maintenance (WLM) diet, either a KD or an isocaloric low-fat diet, with the first 2 weeks being a gradual refeeding.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 30-45 kg/m2
- •Both men and women
- •Age between 18-65 years
- •Sedentary to moderately active (<2 h/wk of moderate, structured, intentional, exercise)
排除标准
- •Pregnancy or lactation
- •Daily use of tobacco (>1 pk/wk)
- •Change in weight greater than 5 lb in the previous 3 months
- •Cognitive impairment
- •Previous bariatric surgery
- •History of eating disorder
- •Presence of any condition (e.g. DM2, PCOS, inflammatory disease, untreated thyroid disease, fluid overload states such as chronic kidney disease, congestive heart failure, or cirrhosis)
- •Use of any medication (e.g., glucocorticoid, GLP-1 analogues, hormone replacement therapy) deemed to interfere with study outcomes.
- •Pre-menopausal women will need to have a regular menstrual cycle (28+/-2 days) or be on hormonal contraceptives
- •Fasting glucose plasma concentration >125 mg/dl and/or HbA1c > 6.4%
研究组 & 干预措施
Ketogenic Diet
Participants randomized to the ketogenic diet will follow a diet with 5% energy from carbohydrates, 70% from fat, and 25% from protein for 6 weeks. The first 2 of the 6 weeks weeks will be a gradual refeeding, with participants slowly withdrawing from the meal replacements used during the 4-week weight loss phase, while introducing more food.
干预措施: Diet Therapy (Behavioral)
Ketogenic Diet
Participants randomized to the ketogenic diet will follow a diet with 5% energy from carbohydrates, 70% from fat, and 25% from protein for 6 weeks. The first 2 of the 6 weeks weeks will be a gradual refeeding, with participants slowly withdrawing from the meal replacements used during the 4-week weight loss phase, while introducing more food.
干预措施: Calorie Restriction (Behavioral)
Ketogenic Diet
Participants randomized to the ketogenic diet will follow a diet with 5% energy from carbohydrates, 70% from fat, and 25% from protein for 6 weeks. The first 2 of the 6 weeks weeks will be a gradual refeeding, with participants slowly withdrawing from the meal replacements used during the 4-week weight loss phase, while introducing more food.
干预措施: Behavioral Support (Behavioral)
Low-Fat Diet
Participants randomized to the low-fat diet will follow a diet with 50% energy from carbohydrates, 25% energy from fat, and 25% energy from protein for 6 weeks. The first 2 of the 6 weeks weeks will be a gradual refeeding, with participants slowly withdrawing from the meal replacements used during the 4-week weight loss phase, while introducing more food.
干预措施: Calorie Restriction (Behavioral)
Low-Fat Diet
Participants randomized to the low-fat diet will follow a diet with 50% energy from carbohydrates, 25% energy from fat, and 25% energy from protein for 6 weeks. The first 2 of the 6 weeks weeks will be a gradual refeeding, with participants slowly withdrawing from the meal replacements used during the 4-week weight loss phase, while introducing more food.
干预措施: Behavioral Support (Behavioral)
Low-Fat Diet
Participants randomized to the low-fat diet will follow a diet with 50% energy from carbohydrates, 25% energy from fat, and 25% energy from protein for 6 weeks. The first 2 of the 6 weeks weeks will be a gradual refeeding, with participants slowly withdrawing from the meal replacements used during the 4-week weight loss phase, while introducing more food.
干预措施: Diet Therapy (Behavioral)
结局指标
主要结局
Change from baseline total energy expenditure
时间窗: Baseline, week 6, week 10
Total Energy Expenditure (TEE) refers to the total amount of energy (calories) your body uses in a day. Twenty-four-hour EE and RQ will be measured inside the whole room indirect calorimeter (chamber) following standard procedures
次要结局
- Change in total body weight(Baseline, week 4, week 6, week 10)
- Change in postprandial glucagon-like peptide-1(Baseline, week 6, week 10)
- Change in total body weight(Baseline, week 4, week 6, week 10)
- Change in appetite ratings(Baseline, week 6, week 10)
- Change in total body composition(Baseline, week 4, week 6, week10)
- Change in fasting insulin(Baseline, week 6, week 10)
- Change in fasting cholecystokinin(Baseline, week 6, week 10)
- Change in fasting ghrelin(Baseline, week 6, week 10)
- Change in fasting glucagon-like peptide-1(Baseline, week 6, week 10)
- Change in mechanical efficiency(Baseline, week 6, week 10)
- Change in resting energy expenditure(Baseline, week 6, week 10)
- Change in postprandial insulin(Baseline, week 6, week 10)
- Change in postprandial cholecystokinin(Baseline, week 6, week 10)
- Change in postprandial ghrelin(Baseline, week 6, week 10)
- Change in postprandial glucagon-like peptide-1(Baseline, week 6, week 10)
- Change in fasting peptide YY (PYY)(Baseline, week 6, week 10)
- Change in postprandial peptide yy(Baseline, week 6, week 10)
- Change in appetite ratings(Baseline, week 6, week 10)
- Change in total body composition(Baseline, week 4, week 6, week10)
- Change in fasting insulin(Baseline, week 6, week 10)
- Change in fasting cholecystokinin(Baseline, week 6, week 10)
- Change in fasting ghrelin(Baseline, week 6, week 10)
- Change in fasting glucagon-like peptide-1(Baseline, week 6, week 10)
- Change in fasting peptide YY (PYY)(Baseline, week 6, week 10)
- Change in mechanical efficiency(Baseline, week 6, week 10)
- Change in resting energy expenditure(Baseline, week 6, week 10)
- Change in postprandial insulin(Baseline, week 6, week 10)
- Change in postprandial cholecystokinin(Baseline, week 6, week 10)
- Change in postprandial ghrelin(Baseline, week 6, week 10)
- Change in postprandial peptide yy(Baseline, week 6, week 10)
- Change in total body composition(Baseline, week 4, week 6, week 10)
研究者
Catia Martins
Associate Professor
University of Alabama at Birmingham