Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker

NCT04319133 | Unknown

• 1 other identifier: 20-02-0153
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The world prevalence of obesity in adult population in 2016 was 650 million while in Indonesia, it has increased from 14,8 percent to 21,8 percent in 2018. Obesity is an established risk factors for metabolic and non communicable- diseases. The purpose of this research was to assess the different effect on waist circumference, insulin resistance and oxidative stress marker between fasting (intervention) group and not fasting (control) group after 8 weeks 5:2 intermittent fasting (IF) among obese male workers.

Conditions

Obesity

Keywords

obesity; intermittent fasting; insulin resistance; stress oxidative marker; waist circumference

Outcome Measures

Primary Outcomes (4)

• insulin resistance

  The pathological condition in which cells fail to respond normally to the hormone insulin. Assessed based on the HOMA-IR value

  8 weeks

• catalase level

  Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg

  8 weeks

• plasma malondialdehyde level

  the concentration of malondialdehyde (1,3-Propanedial) in the plasma as an oxidative stress marker measured by means of Will's method expressed in nmol/ml plasma unit

  8 weeks

• waist circumference

  One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease. expressed in centimeter.

  8 weeks

Secondary Outcomes (1)

• mean caloric intake

  8 weeks

Study Arms (2)

intervention

EXPERIMENTAL

Participants will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks

Behavioral: Fasting

control

NO INTERVENTION

Participants will not doing fasting or intake restriction within 8 weeks

Interventions

Fasting BEHAVIORAL

Doing fasting 2 days a week within 8 weeks

intervention

Eligibility Criteria

• Age: 30 Years - 59 Years
• Gender Eligibility Details: menstruating women will lose blood, so if they still asked to fast, it can endanger themselves because the nutrition is getting less
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men aged 30-59 years
• Has a BMI ≥ 25 kg/m\^2
• Has a waist circumference of ≥ 90 cm
• Willingness to participate in the whole study by signing informed consent

You may not qualify if:

• Doing regular fasting (2 days a week) for 12 weeks before the study begins.
• In a certain diet at the moment
• Participants who are taking drugs that can affect blood sugar, insulin, and drugs (steroids, beta blockers, adrenergics), vitamins or herbal supplements and other drugs that affect oxidative stress.
• Participants suffering from obesity with complications such as impaired liver function, impaired kidney function, heart disease and type 2 diabetes mellitus are known through anamnesis and physical examination as well as fasting blood sugar checks.
• Participants that has a fever with temperatures\> 37.5 ℃

Sponsors & Collaborators

• Anni Rahmawati: lead

Study Sites (1)

PT DELAMITA BiILANO

Jakarta, 13260, Indonesia

Location

Related Publications (3)

• Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.

  PMID: 29754952 RESULT

• Conley M, Le Fevre L, Haywood C, Proietto J. Is two days of intermittent energy restriction per week a feasible weight loss approach in obese males? A randomised pilot study. Nutr Diet. 2018 Feb;75(1):65-72. doi: 10.1111/1747-0080.12372. Epub 2017 Aug 9.

  PMID: 28791787 RESULT

• Witjaksono F, Prafiantini E, Rahmawati A. Effect of intermittent fasting 5:2 on body composition and nutritional intake among employees with obesity in Jakarta: a randomized clinical trial. BMC Res Notes. 2022 Oct 12;15(1):323. doi: 10.1186/s13104-022-06209-7.

  PMID: 36224641 DERIVED

MeSH Terms

Conditions

Obesity; Intermittent Fasting; Insulin Resistance

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Anni Rahmawati, postgraduate

  Ilmu Gizi Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anni Rahmawati, postgraduate

CONTACT

6285260074015; annibustami@gmail.com

Karima Yudhistina, postgraduate

CONTACT

6282126002211; karimayudhistina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Student

Model Details: Overall, this research will run for ± 10 weeks; 1 week of preparation, 8 weeks of intervention and 1 week of evaluation of the final results of the study. This research will involve an interview, physical examination and laboratory examination. This research is a clinical trial research with interventions in the form of fasting. There will be divided into two groups: the intervention group (fasting) and the control group (not fasting). The fasting group will fast every Monday and Thursday, while the fasting group consumes daily food as usual. Both groups will be given education about balanced nutrition.

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 10, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)