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Time-Restricted Feeding on Glucose Homeostasis and Quality of Life

11 december 2019 bijgewerkt door: Dr. Ebaa Al Ozairi, Dasman Diabetes Institute

A Pilot Study to Evaluate the Effect of Time-Restricted Feeding on Blood Glucose, Insulin Sensitivity and Quality of Life

Background: Time-restricted feeding can improve insulin sensitivity, and increase fat oxidation in people with prediabetes independent of weight loss. It may also help people to lose weight. However, it has not been tested in people with type 2 diabetes.

Plan of investigation: Participants meeting the eligibility criteria will be randomized to the TRF arm or the continuous eating arm. Both arms with be given a prescribed dietary plan to help them lose 5% of body weight. In the TRF they will permitted to eat between midday and 6pm. In the continuous eating arm they will be allowed to eat between 8am and 11pm. Participants will attend the nutrition clinic every two weeks to be weighed and be given personalized support to help them follow their assigned diet. Prior to starting the diets outcome measures will be taken: Glycaemia will be measured by a glucose tolerance test, and 7-day continuous glucose monitoring. HbA1c will be taken from fasting blood sample. In addition, the fasting sample will be taken for measurement of insulin, lipid profile and inflammatory markers. We will also use questionnaires to assess quality of life, a 3-day food diary to assess compliance to diet especially meal timings. Capillary ketones will also be used to assess whether compliance to the assigned fasting period. Outcome measures will also be taken during 7 days of the second month, and then the final seven days of the last month on the diet. The primary outcome is HbA1c.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Experimental Design

12-week parallel randomised control trial

Recruitment

We will recruit via advertisements outside Dasman using social media and local ads in addition to screening of Dasman Registry for any potential participants. Opportunistic recruitment will also occur by DDI dietitians. Following telephone screening to ensure the potential participant meets initial screening criteria we will carry out a medical screening to ensure the person can take part.

Environment All screening, dietary counselling visits, and placement of the CGM will take place at the Dasman Diabetes Institute (DDI). The institute has extensive space for interventional studies, including screening rooms, body composition assessment and clinical rooms for placement of the CGM monitor.

STUDY INTERVENTIONS

For both groups all participants will be guided towards a 5% weight loss based on individualised energy requirements. The difference will be the hours during which the participants consume their required calories.

  • Time restricted feeding group: Will consume their calories between 12pm and 6pm.
  • Continuous energy restriction group: Will consume their calories between 8am and 11pm.

Participants will be guided towards their weight loss during one-to-one visits at baseline and every 2 weeks for 12 weeks.

Procedures

  • At baseline and follow-up all participants will undergo an oral glucose tolerance test.
  • A blood sample will also be taken for HbA1c, lipid profile, fasting insulin, inflammatory factors and a sample for Biobank. The biobank sample will be stored to enable us, with other researchers at DDI to understand the heterogeneity of type 2 diabetes; whether certain people respond to dietary interventions based on their genetic, epigenetic or metabolomic background; and ultimately will help guide clinical care.
  • Participants will wear Flash Glucose monitoring or other continuous glucose monitoring device to measure their 24-hour blood glucose concentrations during the seven days preceding the start of the dietary intervention, seven days of the second month, and the final seven days of the third month.
  • Participants will also measure their capillary ketones during the first three days of the first month, three days of the second month, and final three days of the third month.
  • Medication changes: prandial medications (insulin or sulphonylurea) will be altered to the timing of meal intake. Any reduction in medication due to changes in glucose will be carried out by the patient's doctor.
  • A quality of life questionnaire: PAID.
  • A 3 day food diary with meal times to check compliance.

Statistical Methods

This is a pilot study. We will recruit 25 people per group. This is based on recommendations for sample sizes for feasibility and pilot studies.

Studietype

Ingrijpend

Inschrijving (Verwacht)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Must agree to follow time restricted feeding protocol if randomized to the TRF arm.
  • Age 21-65 years
  • T2DM with any diabetes medication
  • BMI of 25-45 kg/m2
  • Wake up at a regular time between 5-8 am
  • Able to provide informed consent.

Exclusion Criteria:

  • Weight loss of more than 5 kg within the past 6 months
  • HbA1c of <6·5% and >12%
  • Serious current or recent illness including cancer or severe or unstable heart failure.
  • Participation in another clinical research trial.
  • Current treatment with anti-obesity drugs.
  • Substance abuse
  • Learning difficulties
  • Presence of an eating disorder
  • Purging behaviour
  • Pregnancy or consideration of pregnancy
  • Hospital admission for depression or use of antipsychotic drugs.
  • Regularly eat within a <9-hour period each day
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: TRF
Eating restricted to between midday and 6pm.
Gedragsmatig: TRF
time restricted feeding group
Placebo-vergelijker: Normal timing of food intake.
Eating between 8am and 11pm.
Gedragsmatig: Normal timing of food intake
no time restricted feeding

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
HbA1c
Tijdsspanne: 12 weeks
Change in HbA1c between the intervention and control arms.
12 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body weight
Tijdsspanne: 12 weeks
Change in body weight between the intervention and control arms.
12 weeks
Insulin sensitivity
Tijdsspanne: 12 weeks
Change insulin sensitivitiy assessed by OGTT between the intervention and control arms.
12 weeks
Diabetes medications
Tijdsspanne: 12 weeks
Change in diabetes medications between the intervention and control arms.
12 weeks
Inflammatory markers
Tijdsspanne: 12 weeks
Change in TNF-alpha in pg/mL between the intervention and control arms.
12 weeks
Inflammatory markers
Tijdsspanne: 12 weeks
Change in IL-10 in pg/mL between the intervention and control arms.
12 weeks
Inflammatory markers
Tijdsspanne: 12 weeks
Change in IL-6 in pg/mL between the intervention and control arms.
12 weeks
Inflammatory markers
Tijdsspanne: 12 weeks
Change in IL-18 in pg/mL between the intervention and control arms.
12 weeks
Inflammatory markers
Tijdsspanne: 12 weeks
Change in CRP in mg/L between the intervention and control arms.
12 weeks
Inflammatory markers
Tijdsspanne: 12 weeks
Change in adiponectin in µg/mL the intervention and control arms.
12 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dasman Diabetes Institute

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 juli 2019

Primaire voltooiing (Verwacht)

1 maart 2020

Studie voltooiing (Verwacht)

1 maart 2020

Studieregistratiedata

Eerst ingediend

18 augustus 2019

Eerst ingediend dat voldeed aan de QC-criteria

18 augustus 2019

Eerst geplaatst (Werkelijk)

20 augustus 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 december 2019

Laatste update ingediend die voldeed aan QC-criteria

11 december 2019

Laatst geverifieerd

1 december 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RA HM-2019-012

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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