NCT04011995

Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk

Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk: a Randomized Controlled Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 9 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overweight
• Obesity
• Cardiometabolic Risk

Interventions

Type	Name	Description
BEHAVIORAL	Intermittent caloric restriction	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.
BEHAVIORAL	Low carbohydrate diet	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.
BEHAVIORAL	Health education on reducing the cardiometabolic risk	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.

Timeline

• Start date: 2018-07-12
• Primary completion: 2021-11-16
• Completion: 2021-12-01
• First posted: 2019-07-09
• Last updated: 2022-03-22

Locations

1 site across 1 country: China