Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk: a Randomized Controlled Pilot Study
Phase: NA
Conditions: Overweight, Obesity, Cardiometabolic Risk
Sponsor: Children's Hospital of Fudan University

 
Effects of intermittent caloric restriction in youth with 
cardiometabolic risk: a randomized controlled pilot study 
 
 
Supplementary Research Ethics Board Approval 
 
NCT number: NCT04011995 
 
 
 
September 20, 2019 

Effects of intermittent caloric restriction in youth with cardiometabolic risk:  
a randomized controlled pilot study 
 
Supplementary Research ethics board approval 
 
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. 
Total trial duration for individual subject is one month consisting of a 14-day 
intervention phase and a 14-day self-maintenance phase. 
 
In the previous study protocol, the eligible subjects were defined as pre-diabetic youth 
aged 13 to 30 years old which were high risk population for cardiometabolic diseases. 
The study was approved by the Research Ethics Committee of the Children’s Hospital 
of Fudan University (CHFU 2017 No. 228) in December 2017. 
 
In 2019, we adjusted the inclusion criteria and expanded the age range of the eligible 
subjects after discussion by the study team. 
The adjusted inclusion criteria are as follows:  
(1) Aged 9-30 years old; 
(2) With at least one of the following cardiometabolic risk: 
 
Overweight or obesity (central obesity or general obesity); 
 
Prediabetes: impaired fasting glucose and/or impaired glucose tolerance; 
 
Dyslipidemia; 
 
Elevated blood pressure. 
 
The previous subjects and the adjusted subjects were from the same population, 
and previous subjects were part of the adjusted study subjects. The protocol after 
adjusting the subjects was also approved by the Research Ethics Committee of the 
Children’s Hospital of Fudan University (CHFU 2019 No. 216) in June 2019.