- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04319133
Effect Of Intermittent Fasting To Metabolic And Oxidative Stress Marker
Effect Of Intermittent Fasting 5: 2 To Waist Circumference, Insulin Resistance And Oxidative Stress Marker In Obese Workers In Jakarta
Studieoversigt
Detaljeret beskrivelse
Intermittent fasting is eating pattern in that cycles between periods of fasting and eating. 5:2 intermittent fasting (IF) is a form of time-restricted fasting which no calories are consumed for at least 14 hours (for 4 am to 6 pm) will done in two non-consecutive days days per week, followed by ad libitum intake on the remaining days, with water restriction too.
Participants will be distributed to each group by simple randomization. This study will access the characteristic data, dietary intake and physical activity from the participants. Anthropometry and blood sample (for insulin resistance (HOMA-IR) and oxidative stress (malondialdehyde and catalase)) were taken at baseline and at the end of the study. Participants from each group will gets counseling at the second week of intervention and they will follow up to 8 weeks with control and evaluation form.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Anni Rahmawati, postgraduate
- Telefonnummer: 6285260074015
- E-mail: annibustami@gmail.com
Undersøgelse Kontakt Backup
- Navn: Karima Yudhistina, postgraduate
- Telefonnummer: 6282126002211
- E-mail: karimayudhistina@gmail.com
Studiesteder
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Jakarta, Indonesien, 13260
- PT DELAMITA BiILANO
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Kontakt:
- Anni rahmawati
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Kontakt:
- Karima yudhistina
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 ℃
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: intervention
Participants will ask to do 5:2 intermittent fasting (2 non-consecutive days a week) within 8 weeks
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Faste 2 dage om ugen inden for 8 uger
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Ingen indgriben: control
Participants will not doing fasting or intake restriction within 8 weeks
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
insulin resistance
Tidsramme: 8 weeks
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The pathological condition in which cells fail to respond normally to the hormone insulin.
Assessed based on the HOMA-IR value
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8 weeks
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catalase level
Tidsramme: 8 weeks
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Enzymatic antioxidant status of endogenous catalase in the blood, expressed in U/mg
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8 weeks
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plasma malondialdehyde level
Tidsramme: 8 weeks
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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
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8 weeks
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waist circumference
Tidsramme: 8 weeks
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One way of anthropometry measurement to assess the visceral fat mass, so that it can evaluate the risk of metabolic disease.
expressed in centimeter.
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8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
mean caloric intake
Tidsramme: 8 weeks
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the average amount of calories consumed daily by the participant which was determined from food diary and subsequent caloric contents calculation expressed in kilocalorie
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8 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Anni Rahmawati, postgraduate, Ilmu Gizi Fakultas Kedokteran Universitas Indonesia
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20-02-0153
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Faste
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Eli Lilly and CompanyAfsluttet
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University of Kansas Medical CenterAfsluttetFedme | Sarkopeni | Kompenseret skrumpeleverForenede Stater