Longitudinal Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Fat mass
研究概览
简要总结
LIMITFOOD is a randomized clinical intervention study that investigates the effects of two different intermittent fasting protocols compared to a control group on the health of normal- and overweight adults. A total of 72 participants will be randomized into three equally sized groups: an alternate day fasting, a time-restricted feeding and a control group.
详细描述
The prevalence of overweight has risen considerably all over the world in the past century. Epidemiological studies have shown that, starting from a body mass index of 20-21 kg/m2, increasing BMI levels are associated with progressively increased risks of developing diabetes, cardiovascular disease, several types of cancer and other diseases. The problem is pronounced by the unlimited and constant availability of food. Treatment of overweight is still difficult and finding effective and more personalized strategies to manage these conditions is crucial.
Intermittent fasting has been suggested as an alternative way to address these problems. Intermittent fasting is an eating pattern that involves rotating periods of eating and fasting. Animal studies and previous human clinical trials have provided evidence that various types of intermittent fasting lead to weight loss and improved health markers not only in obese, but also in healthy, non-obese adults.There are several types of intermittent fasting. The most popular version is time-restricted feeding (TRF), which allows ad libitum (at one's pleasure) energy intake within a defined period of time each day (6-12h). Another subtype of IF is called alternate day fasting (ADF). ADF is defined as 'feast days' on which food is consumed ad libitum, which alternate with 'fast days' on which food is withheld or reduced.
However, despite the growing popularity of intermittent fasting, it is not clear which type of IF is most effective and what fasting window is needed to induce beneficial effects. Additionally, tools to longitudinally track personal progress of dieting are lacking. Therefore, the main objective of this study is to compare the effects of each of two different intermittent fasting protocols (TRF and ADF) on metabolic parameters to a control group. Furthermore, a new dynamic measurement technique, using breath analysis, will allow to better monitor the progress of individual participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-40 years, both inclusive
- •Non-obese, BMI between 23 and 30 kg/m2, both inclusive
- •Non-smoker
- •Good knowledge of German or English language
- •Stable weight change (change < +/- 10% current bodyweight) for 3 months prior to the study
- •Glycohemoglobin (HbA1c) < 5.7% without glucose lowering medication
- •LDL-cholesterol < 180 mg/dl without lipid lowering medication
- •Blood pressure < 140/90 mmHG without blood pressure lowering medication
排除标准
- •Subjects who have a fasting period of > 12h per day on a regular basis and do not eat at least three main meals per day.
- •Current habitual use of dietary supplements (e.g. vitamins, minerals) and/or unwillingness to cease intake of dietary supplements.
- •Antibiotics intake during 3 months prior to the study
- •Food intolerances, allergies and sensitivities (e.g. lactose/gluten intolerance, food allergies) or dietary restrictions (e.g. vegan lifestyle)
- •Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in the study.
- •Known alcohol, substance or drug abuse, concomitant medication
- •More than four hours of physical exercise per week
- •Women who are pregnant, breast-feeding or aiming to become pregnant during course of the trial
- •Women and men on hormonal supplementation
- •Women with a very irregular menstrual cycle
- •Therapy with antidepressants within the past 6 months
- •Regular therapy with acetylsalicyclic acid or current medication to regulate blood sugar, blood pressure or lipids
- •Subjects likely to fail to comply with the study protocol
- •Subjects who do not give informed consent
结局指标
主要结局
Fat mass
时间窗: 4 weeks
Change in whole body fat mass
次要结局
- Continuous glucose monitoring (CGM)(4 weeks)
- Physical activity energy expenditure(4 weeks)
- Resting metabolic rate (measured by indirect calorimetry)(4 weeks)
研究者
Philipp Gerber
MD, MSc, Senior Physician / Group Leader
University of Zurich