Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk

NCT04011995 | Completed

• 1 other identifier: ICR_2019_2.0
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Cardiometabolic Risk

Keywords

Intermittent caloric restriction; Children; Youth

Outcome Measures

Primary Outcomes (1)

• Reversal of cardiometabolic abnormalities

  The primary outcome is a composite outcome that will be measured by combining multiple reverse outcomes of the following cardiometabolic abnormalities: (1) overweight or obesity, (2) prediabetes, (3) hyperlipidemia and (4) elevated blood pressure. It is defined as occurring if any cardiometabolic abnormality has a reversal outcome at the 14th day of dietary intervention phase. Reversal of cardiometabolic abnormalities is defined as: At the 14th day of dietary intervention phase, at least one of the following indicators changed from abnormal at baseline to normal: overweight, obesity, prediabetes, hyperlipidemia and elevated blood pressure. (The reversal of overweight or obesity is defined according to reference\[1, 2\]: For subject with general obesity at baseline: weight loss of 1.5 kg after intervention; For subject with central obesity at baseline: waist circumference reduction of 1.5 cm after intervention.)

  From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.

Secondary Outcomes (13)

• Change in insulin

  From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.

• Change in insulin-like growth factor-1

  From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.

• Change in mean blood glucose

  From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.

• Change in gut microbial compositions

  From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.

• Change in body weight

  From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase.

Study Arms (2)

Intermittent caloric restriction

EXPERIMENTAL

Behavioral: Intermittent caloric restriction; Behavioral: Health education on reducing the cardiometabolic risk

Low carbohydrate diet

ACTIVE COMPARATOR

Behavioral: Low carbohydrate diet; Behavioral: Health education on reducing the cardiometabolic risk

Interventions

Intermittent caloric restriction BEHAVIORAL

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.

Also known as: Intermittent fasting

Intermittent caloric restriction

Low carbohydrate diet BEHAVIORAL

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.

Low carbohydrate diet

Health education on reducing the cardiometabolic risk BEHAVIORAL

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.

Intermittent caloric restriction; Low carbohydrate diet

Eligibility Criteria

• Age: 9 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have at least one of the following cardiometabolic abnormalities:
• Overweight or obesity (central obesity or general obesity)
• Prediabetes: impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT)
• Dyslipidemia
• Elevated blood pressure
• Criteria for cardiometabolic abnormalities:
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, China

Location

Related Publications (3)

• 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.

  PMID: 20921964 BACKGROUND

• 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.

  PMID: 28465792 BACKGROUND

• Dou Y, Jiang Y, Chen X, Zhang Y, Wang Y, Chen H, He W, Yan W. Intermittent dietary carbohydrate restriction versus calorie restriction and cardiometabolic profiles: A randomized trial. Obesity (Silver Spring). 2023 Sep;31(9):2260-2271. doi: 10.1002/oby.23855. Epub 2023 Aug 7.

  PMID: 37545298 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 9, 2019
• Study Start: July 12, 2018
• Primary Completion: November 16, 2021
• Study Completion: December 1, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Locations

CN (1)