Back to results

Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk

Primary Purpose

Overweight, Obesity, Cardiometabolic Risk

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Intermittent caloric restriction

Low carbohydrate diet

Health education on reducing the cardiometabolic risk

About this trial

This is an interventional prevention trial for Overweight focused on measuring Intermittent caloric restriction, Children, Youth

Eligibility Criteria

9 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Based on recommendation of American Diabetes Association.
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.
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:

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

Sites / Locations

Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent caloric restriction

Low carbohydrate diet

Arm Description

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Change in insulin

Serum from fasting blood sample is used for measurement of insulin.

Change in insulin-like growth factor-1

Fasting blood sample for measurement of insulin-like growth factor-1.

Change in mean blood glucose

Measured by a blood glucose monitor for 24-hour glucose monitoring during the 14-day intervention phase.

Change in gut microbial compositions

Stool sample of subject is used for measurement of gut microbial compositions.

Change in body weight

Body weight is measured according to the Physical Fitness and Health Surveillance of Chinese School Students by trained, certified study staff. It is measured to the nearest 0.1 kg.

Change in body weight

Body weight is measured by subject and reported by electronic questionnaire. It is measured to the nearest 0.1 kg.

Change in waist circumference

Waist circumference is measured to the nearest 0.1 cm using a constant tension tape around the waist at 1 cm below the navel as the subject exhaled. It is calculated as the average value of two measurements.

Change in waist circumference

Waist circumference is measured by subject and reported by electronic questionnaire. It is measured to the nearest 0.1 cm using a constant tension tape around the waist at 1 cm below the navel as the subject exhaled. It is calculated as the average value of two measurements.

Dietary energy intake

Daily dietary energy intake (kcals/day) is calculated by researchers using food weighing photos of the subject.

Self-reported dietary adherence

Adherence to diet will be assessed with a electronic questionnaire in the self-maintenance phase.

Change in monocyte chemoattractant protein-1 (MCP-1)

MCP-1 will be measured by enzyme-linked immunosorbent assays (R&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.

Change in free fatty acid (FFA)

FFA will be measured by enzyme-linked immunosorbent assays (R&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.

Change in fibroblast growth factor 21 (FGF-21)

FGF-21 will be measured by enzyme-linked immunosorbent assays (R&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.

Full Information

NCT ID

NCT04011995

First Posted

July 4, 2019

Last Updated

March 7, 2022

Sponsor

Children's Hospital of Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04011995

Brief Title

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

July 12, 2018 (Actual)

Primary Completion Date

November 16, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity, Cardiometabolic Risk

Keywords

Intermittent caloric restriction, Children, Youth

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intermittent caloric restriction

Arm Type

Experimental

Arm Title

Low carbohydrate diet

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Intermittent caloric restriction

Other Intervention Name(s)

Intermittent fasting

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Low carbohydrate diet

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Health education on reducing the cardiometabolic risk

Intervention Description

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.

Primary Outcome Measure Information:

Title

Reversal of cardiometabolic abnormalities

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in insulin

Description

Serum from fasting blood sample is used for measurement of insulin.

Time Frame

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

Title

Change in insulin-like growth factor-1

Description

Fasting blood sample for measurement of insulin-like growth factor-1.

Time Frame

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

Title

Change in mean blood glucose

Description

Measured by a blood glucose monitor for 24-hour glucose monitoring during the 14-day intervention phase.

Time Frame

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

Title

Change in gut microbial compositions

Description

Stool sample of subject is used for measurement of gut microbial compositions.

Time Frame

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

Title

Change in body weight

Description

Body weight is measured according to the Physical Fitness and Health Surveillance of Chinese School Students by trained, certified study staff. It is measured to the nearest 0.1 kg.

Time Frame

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

Title

Change in body weight

Description

Body weight is measured by subject and reported by electronic questionnaire. It is measured to the nearest 0.1 kg.

Time Frame

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

Title

Change in waist circumference

Description

Time Frame

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

Title

Change in waist circumference

Description

Time Frame

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

Title

Dietary energy intake

Description

Daily dietary energy intake (kcals/day) is calculated by researchers using food weighing photos of the subject.

Time Frame

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

Title

Self-reported dietary adherence

Description

Adherence to diet will be assessed with a electronic questionnaire in the self-maintenance phase.

Time Frame

At the 14th day of the self-maintenance phase.

Title

Change in monocyte chemoattractant protein-1 (MCP-1)

Description

MCP-1 will be measured by enzyme-linked immunosorbent assays (R&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.

Time Frame

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

Title

Change in free fatty acid (FFA)

Description

FFA will be measured by enzyme-linked immunosorbent assays (R&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.

Time Frame

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

Title

Change in fibroblast growth factor 21 (FGF-21)

Description

FGF-21 will be measured by enzyme-linked immunosorbent assays (R&D Systems, Inc. USA), using fasting serum samples at baseline and 14 days after intervention.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Based on recommendation of American Diabetes Association. 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. 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: Diagnosis of severe diseases such as cardiac insufficiency, severe malnutrition or immunodeficiency. History of bariatric surgery. Use of antiobesity drugs or supplements.

Facility Information:

Facility Name

Children's Hospital of Fudan University

City

Shanghai

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

20921964

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.

Results Reference

background

PubMed Identifier

28465792

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.

Results Reference

background

Learn more about this trial

Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk

We'll reach out to this number within 24 hrs