A Pilot Study Investigating the Acceptability and Impact of the Mediterranean Diet and Intermittent Fasting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility and acceptability of intervention
研究概览
简要总结
This clinical trial attempts to evaluate the feasibility and acceptability of an intervention combining intermittent fasting and the Mediterranean diet guidelines vs an comparative intervention combining intermittent fasting but using the UK dietary guidelines.
Participants will be randomised to these intervention using a parallel design. Weight change and blood lipids will be assessed.
详细描述
This study will have a randomised parallel study comparing two interventions involving intermittent fasting. One of the interventions will use the Mediterranean dietary guidelines proposed by the Mediterranean Diet Foundation, the other intervention will use the UK dietary guidelines (Eatwell Guide).
In this study, the interventions will require participants to adopt these interventions for 4 weeks. A basic website containing support information will be develop for each of these interventions.
Baseline measurements will be taken at the start of the study. Blood samples will be obtained in a fasted state before and after 4-week study period.
Anthropometric and body composition measurements including height and weight, waist circumference, bioelectrical impedance will be collected by researcher. Physical activity will be assessed using accelerometers.
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
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-70 yrs BMI 25-39.9kg/m2, Able to attend university for measurement and educational sessions.
排除标准
- •Cardiovascular problems or documented history of CVD including: angina; myocardial infarction; coronary revascularization procedures; stroke (ischemic or haemorrhagic, including transient ischemic attacks) symptomatic peripheral artery disease that required surgery or was diagnosed with vascular imaging techniques; ventricular arrhythmia; uncontrolled atrial fibrillation; congestive heart failure; hypertrophic myocardiopathy, or aortic aneurism,
- •Active malignant cancer or history of malignancy within the last 5 years (except non-melanoma skin cancer)
- •Issues affecting food intake e.g. dysphagia, severe allergies, food neophobia, strong dislike of foods in diet plan, or religious issues
- •Lack of motivation to change diet/lifestyle (low likelihood as calculated according to the Prochaska and DiClemente Stages of Change Model)
- •Lack of motivation to fast Medical reasons not allowing very low calorie intake, type 1 or 2 diabetes
- •Pregnancy or hoping to become pregnant, or breastfeeding
- •Current adherence to other weight loss or exercise program
- •Illiteracy or inability/unwillingness to give written informed consent or communicate with study staff
- •Institutionalization
- •History of surgical procedures for weight loss or intention to undergo bariatric surgery in the next 12 months
- •Obesity of known endocrine origin (e.g. hypothyroidism, polycystic ovarian syndrome)
- •Serious psychiatric disorders including: schizophrenia, bipolar disorder, eating disorders, or depression with hospitalization within the last 6 months
- •Alcohol abuse or addiction (or total daily alcohol intake >50 g) or drug abuse within the past 6 months
- •Current use of weight loss medication
研究组 & 干预措施
Mediterranean diet plus intermittent fasting
For 4 weeks participants will be encouraged to adopt the Mediterranean dietary guidelines as recommended by the Mediterranean Diet Foundation in Barcelona, Spain. In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days.
干预措施: Mediterranean diet guidelines plus intermittent fasting (Behavioral)
Eatwell guide plus intermittent fasting
For 4 weeks participants will be encouraged to adopt the UK dietary guidelines (Eatwell Guide). In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days.
干预措施: UK Eatwell guidelines plus intermittent fasting (Behavioral)
结局指标
主要结局
Feasibility and acceptability of intervention
时间窗: 4 weeks
Participants will complete a questionnaire directed to obtain early markers of how the intervention is used
次要结局
- Weight change(4 weeks)
- Total cholesterol(4 weeks)
- Change from baseline physical activity levels at 2 months(4 weeks)
- Change from baseline dietary intake(4 weeks)
研究者
Jose Lara Gallegos
Senior Lecturer
Northumbria University