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Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk

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ClinicalTrials.gov Identifier: NCT04011995
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Weili Yan, Children's Hospital of Fudan University

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Cardiometabolic Risk Behavioral: Intermittent caloric restriction Behavioral: Low carbohydrate diet Behavioral: Health education on reducing the cardiometabolic risk Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Intermittent Caloric Restriction in Youth With Cardiometabolic Risk: a Randomized Controlled Pilot Study
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Intermittent caloric restriction 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.

Other Name: Intermittent fasting

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.

Active Comparator: Low carbohydrate diet 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.




Primary Outcome Measures :
  1. Reversal of cardiometabolic abnormalities [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase. ]

    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 :
  1. Change in insulin [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase. ]
    Serum from fasting blood sample is used for measurement of insulin.

  2. Change in 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. ]
    Fasting blood sample for measurement of insulin-like growth factor-1.

  3. Change in mean blood glucose [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase. ]
    Measured by a blood glucose monitor for 24-hour glucose monitoring during the 14-day intervention phase.

  4. Change in gut microbial compositions [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase. ]
    Stool sample of subject is used for measurement of gut microbial compositions.

  5. Change in body weight [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase. ]
    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.

  6. Change in body weight [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the self-maintenance phase. ]
    Body weight is measured by subject and reported by electronic questionnaire. It is measured to the nearest 0.1 kg.

  7. Change in waist circumference [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase. ]
    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.

  8. Change in waist circumference [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the self-maintenance phase. ]
    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.

  9. Dietary energy intake [ Time Frame: From the baseline (the first day of the intervention phase) to the 14th day of the intervention phase. ]
    Daily dietary energy intake (kcals/day) is calculated by researchers using food weighing photos of the subject.

  10. Self-reported dietary adherence [ Time Frame: At the 14th day of the self-maintenance phase. ]
    Adherence to diet will be assessed with a electronic questionnaire in the self-maintenance phase.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011995


Contacts
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Contact: Weili Yan, PhD +86 21 64931215 yanwl@fudan.edu.cn

Locations
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China
Children's Hospital of Fudan University Recruiting
Shanghai, China
Contact: Weili Yan, PhD         
Sponsors and Collaborators
Children's Hospital of Fudan University
  Study Documents (Full-Text)

Documents provided by Weili Yan, Children's Hospital of Fudan University:
Statistical Analysis Plan  [PDF] September 22, 2019
Study Protocol  [PDF] September 20, 2019

Publications:
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Responsible Party: Weili Yan, Professor, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04011995    
Other Study ID Numbers: ICR_2019_2.0
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weili Yan, Children's Hospital of Fudan University:
Intermittent caloric restriction
Children
Youth
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms