Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk
Condition: Overweight; Obesity; Cardiometabolic Risk
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This is a randomized controlled pilot study to evaluate the effects of intermittent caloric
      restriction compared with low carbohydrate diet in youth with cardiometabolic risk.
    

Detailed description: 
      The National China Health and Nutrition Survey revealed that 42% of overweight children had
      at least one cardiovascular metabolic risk, such as hyperglycaemia, dyslipidemia or
      hypertension. Non-pharmaceutical life style modifications are the recommended intervention to
      these subjects, including caloric restriction and increased physical activity. However, the
      problems of poor compliance and metabolic adaptation are well known. Evidences from a number
      studies in rodent models and human indicated that intermittent caloric restriction (ICR) may
      stimulate series reactions in human body, including improvement of insulin sensitivity, blood
      pressure, oxidative stress and inflammation, and may be easier to follow. Evidence from
      larger human studies is strongly encouraged, while the effects, safety and adherence in
      chidren and youth need to be studied.

      This study is a randomized controlled trial of intermittent caloric restriction versus low
      carbohydrate diet in youth with cardiometabolic risk over one month period. The intervention
      is based on the 5:2 diet, which involves caloric restriction for 2 days (consecutive or
      nonconsecutive, 600kcal/d for male and 500kcal/d for female) per week and unrestricted eating
      during the other 5 days of the week. For control group, the subjects receive 7 days
      (consecutive or nonconsecutive) of low carbohydrate diet intervention during the 14-day
      intervention period,. Carbohydrate intake of low-carbohydrate diet should be controlled as ≤
      50g per day. Total trial duration is one month consisting of a 14-day intervention phase and
      a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic
      questionnaires were conducted.

      The study aim to explore effects of the dietary interventions on cardiometabolic markers,
      inflammatory reaction, oxidative stress and gut microbiome in youth with cardiometabolic
      risk.
    

Intervention name(s): Intermittent caloric restriction; Low carbohydrate diet; Health education on reducing the cardiometabolic risk
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The intervention is based on the 5:2 diet, which involves caloric restriction for 2 days (consecutive or nonconsecutive, 600kcal/d for male and 500kcal/d for female) per week and unrestricted eating during the other 5 days of the week.
Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted.; During the 14-day intervention period, the subjects receive 7 days (consecutive or nonconsecutive) of low carbohydrate diet intervention. Carbohydrate intake of low-carbohydrate diet should be controlled as ≤ 50g per day.
Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted.; Health education is conducted once a week during 14-day dietary intervention for all subjects. Health education including the understanding of cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health.
Other intervention name(s): Intermittent fasting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intermittent caloric restriction; Children; Youth