Does the Energy Restriction Intermittent Fasting Diet Alleviate Metabolic Syndrome Biomarkers?

NCT04502329 | Completed DMC

• 1 other identifier: 10840098-604.01.01-E.1866
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled study determine the efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight management among metabolic syndromes adults. It was done on metabolic syndrome patients, aged 18-65 years at an academic institution in Istanbul,Turkey. Subjects were divided into two groups; IER (Intermittent Energy Restriction-intervention group, calori restriction of 300-500kcal/d combined with 16:8 model Intermittent Fasting) and CER (Countinous Energy Restriction- control group continous restriction of 300-500kcal/d). Assessment was ascertained at baseline and 12 weeks. Blood samples were analyzed for lipid profile, fasting plasma glucose, ınsulin, HOMA-IR. Blood pressure and body composition were evaluated.

Conditions

Metabolic Syndrome

Keywords

intermittent fasting; metabolic syndrome; time restricted diet; energy restriction

Outcome Measures

Primary Outcomes (16)

• Average weight and standard deviation of the participants

  Weight in kilograms, was measured with TANİTA SC-330 instrument.

  Change from Baseline Weight at 12 weeks

• Average height and standard deviation of the participants

  Height measured with SECA-213 instrument.

  Baseline

• Average Body Mass Indexand standard deviation of the participants

  Weight and Height were combined to report BMI in kg/m\^2

  Change from Baseline Body Mass Index at 12 weeks

• Average Waist circumference and standard deviation of the participants

  Waist circumference in centimeters, was measured by the same dietician with the help of unstretched tape measure.

  Change from Baseline Weight at 12 weeks

• Concentration of Total Cholesterol

  Total cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.

  Change from Baseline Weight at 12 weeks

• Concentration of High-Density Cholesterol

  High Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.

  Change from Baseline Weight at 12 weeks

• Concentration of Low-Density Cholesterol

  Low Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.

  Change from Baseline Weight at 12 weeks

• Concentration of Triglyceride

  Triglyceride in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.

  Change from Baseline Weight at 12 weeks

• Concentration of Fasting plasma glucose

  Fasting plasma glucose in mg/dL, was provided from participant's clinician before and 12 weeks after diet.

  Change from Baseline Weight at 12 weeks

• Concentration of Insülin

  Insülin in IU/L, was provided from participant's clinician before and 12 weeks after diet.

  Change from Baseline Weight at 12 weeks

• Rate of HOMA-IR

  HOMA-IR was calculated with fasting plasma glucose and insülin levels. HOMA-IR = (Fasting plasma glucose \[mg/dL\] x Insülin \[IU/L\] ) / 405

  Change from Baseline Weight at 12 weeks

• Concentration of HbA1c

  HbA1c what value was stated as a percentage (%), were provided from participant's clinician before and 12 weeks after diet.

  Change from Baseline Weight at 12 weeks

• Amount of Fat mass

  Fat mass in kilograms was measured with TANİTA SC-330 instrument.

  Change from Baseline Weight at 12 weeks

• Rate of Body fat percentage

  Body fat percentage was calculated combined with weight and fat mass. Body fat percentage = (Body mass \[kg\] / Weight \[kg\]) x 100.

  Change from Baseline Weight at 12 weeks

• Amount of Fat free mass

  Fat free mass in kilograms, was measured with TANİTA SC-330 instrument.

  Change from Baseline Weight at 12 weeks

• Amount of Total body water

  Total body water in kilograms, was measured with TANİTA SC-330 instrument.

  Change from Baseline Weight at 12 weeks

Study Arms (2)

IER

EXPERIMENTAL

Intermittent Energy Restriction

Other: Diet

CER

NO INTERVENTION

Continous Energy Restriction

Interventions

Diet OTHER

Energy Restriction Intermittent Fasting Diet

IER

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being between the ages of 18-65
• Body mass index to be 27 and above
• Clinical diagnosis of metabolic syndrome according to the criteria of IDF 2005 or NCP ATP III.

You may not qualify if:

• Being in the pre-menopausal or menopause
• Following a special diet (such as Celiac, Type 1 diabetes)
• Using a special nutritional supplement (omega 3, probiotic, vitamin-mineral, teff seed etc.)
• Those who do not comply with the diet, pregnant, being lactating
• Doing heavy physical activity or working in a heavy job
• Presence of liver, kidney or immune deficiency
• Conditions that will seriously affect weight management such as having bariatric surgery
• Determined to have had an unintentional sudden weight loss of more than 5% in the last three months
• Not be practicing Muslim Ramadan fasting or had changed their dietary pattern 12 weeks before the study

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Welton S, Minty R, O'Driscoll T, Willms H, Poirier D, Madden S, Kelly L. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020 Feb;66(2):117-125.

  PMID: 32060194 RESULT

• Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442.

  PMID: 31614992 RESULT

• Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.

  PMID: 28715993 RESULT

• Antoni R, Johnston KL, Collins AL, Robertson MD. Effects of intermittent fasting on glucose and lipid metabolism. Proc Nutr Soc. 2017 Aug;76(3):361-368. doi: 10.1017/S0029665116002986. Epub 2017 Jan 16.

  PMID: 28091348 RESULT

MeSH Terms

Conditions

Metabolic Syndrome; Intermittent Fasting

Interventions

Diet

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fasting; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Dietitian

Model Details: Randomized control trial The first participant assigned Intermittent Energy Restriction Group, the others assigned Continous Energy Restricition group or Intertermittent Energy Restriction Group respectively.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: August 6, 2020
• Study Start: January 30, 2019
• Primary Completion: March 10, 2020
• Study Completion: June 10, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)