MedTrace Logo

Time-Restricted Feeding on Glucose Homeostasis and Quality of Life

NCT04062773 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-12-13

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Time Restricted Feeding

Interventions

BEHAVIORAL

TRF

time restricted feeding group

BEHAVIORAL

Normal timing of food intake

no time restricted feeding

Sponsors & Collaborators

  • Dasman Diabetes Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-10
Primary Completion
2020-03-01
Completion
2020-03-01

Countries

  • Kuwait

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062773 on ClinicalTrials.gov