Clinical trial NCT04011995: Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk
Official title: Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Cardiometabolic Risk
Keywords: Intermittent caloric restriction
Children
Youth
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 34
Sex: ALL
Minimum age (years): 9
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

Have at least one of the following cardiometabolic abnormalities:

1. Overweight or obesity (central obesity or general obesity)
2. Prediabetes: impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)
3. Dyslipidemia
4. Elevated blood pressure

Criteria for cardiometabolic abnormalities:

1. Overweight or obesity

   For subjects (9 ≤ age ≤ 18 years) :

   • General obesity: Body mass index higher than the 85th percentile for overweight and the 90th percentile for obesity, based on the references for screening overweight and obesity in Chinese children and adolescents.

   • Central obesity: Waist circumference higher than the 90th percentile of the age and gender-specific reference for screening cardiovascular risk factors in Chinese children and adolescents.

   For subjects ( 19 ≤ age ≤ 30 years) :

   • General obesity: Body mass index between 24.0 and 27.9 kg/m2 for overweight and ≥28 kg/m2 for obesity.

   • Central obesity: Waist circumference ≥85cm for men and ≥80cm for female. Based on recommendation of overweight and obesity in Chinese adults.
2. Prediabetes:

   With IFG and/or IGT. IFG: fasting glucose from 5.6 to 6.9 mmol/L; IGT: 2-h glucose in the 75g oral glucose tolerance test from 7.8 to 11.0 mmol/L.

   Based on recommendation of American Diabetes Association.
3. Dyslipidemia:

   For subjects (9 ≤ age ≤ 18 years) :

   Triglycerides of ≥1.70 mmol/L or total cholesterol of ≥5.18 mmol/L or lowdensity lipoprotein cholesterol ≥3.37 mmol/L or highdensity lipoprotein cholesterol of ≤1.04 mmol/L. Based on recommendation in Chinese children and adolescents.

   For subjects ( 19 ≤ age ≤ 30 years) :

   Triglycerides of ≥1.7 mmol/L or total cholesterol of ≥5.2 mmol/L or lowdensity lipoprotein cholesterol ≥3.4 mmol/L or highdensity lipoprotein cholesterol of ≤1.0 mmol/L. Based on guideline for the management of dyslipidemia in Chinese adults.
4. Elevated blood pressure:

For subjects (9 ≤ age ≤ 18 years) :

Blood pressure higher than the 90th percentile of blood pressure age and gender-specific reference standards for Chinese children and adolescents, or blood pressure \>120/80 mmHg.

For subjects ( 19 ≤ age ≤ 30 years) :

Systolic blood pressure≥120 mmHg and/or diastolic blood pressure ≥80 mmHg. Based on Chinese guidelines for the management of hypertension.

Exclusion Criteria:

1. Diagnosis of severe diseases such as cardiac insufficiency, severe malnutrition or immunodeficiency.
2. History of bariatric surgery.
3. Use of antiobesity drugs or supplements.

Primary outcomes:
measure: Reversal of cardiometabolic abnormalities
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Secondary outcomes:
measure: Change in insulin
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Change in insulin-like growth factor-1
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Change in mean blood glucose
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Change in gut microbial compositions
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Change in body weight
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Change in body weight
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the self-maintenance phase.
measure: Change in waist circumference
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Change in waist circumference
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the self-maintenance phase.
measure: Dietary energy intake
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Self-reported dietary adherence
timeFrame: At the 14th day of the self-maintenance phase.
measure: Change in monocyte chemoattractant protein-1 (MCP-1)
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Change in free fatty acid (FFA)
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
measure: Change in fibroblast growth factor 21 (FGF-21)
timeFrame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
References:
citation: Harvie MN, Pegington M, Mattson MP, Frystyk J, Dillon B, Evans G, Cuzick J, Jebb SA, Martin B, Cutler RG, Son TG, Maudsley S, Carlson OD, Egan JM, Flyvbjerg A, Howell A. The effects of intermittent or continuous energy restriction on weight loss and metabolic disease risk markers: a randomized trial in young overweight women. Int J Obes (Lond). 2011 May;35(5):714-27. doi: 10.1038/ijo.2010.171. Epub 2010 Oct 5.
citation: Arnason TG, Bowen MW, Mansell KD. Effects of intermittent fasting on health markers in those with type 2 diabetes: A pilot study. World J Diabetes. 2017 Apr 15;8(4):154-164. doi: 10.4239/wjd.v8.i4.154.