| Study name |
Time‐restricted feeding on glucose homeostasis and quality of life |
| Methods |
12 wk Randomised controlled trial |
| Participants |
50 participants. Ages Eligible for Study: 21 years to 65 years (adult, older adult)
Sexes Eligible for Study: all
Accepts Healthy volunteers: no
Inclusion Criteria
Must agree to follow time restricted feeding protocol if randomised 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 am to 8 am
Able to provide informed consent. |
| Interventions |
Arm Intervention/treatment
Experimental: TRF
Eating restricted to between midday and 6 pm.
Behavioural: TRF
Time restricted feeding group
Placebo comparator: normal timing of food intake.
Eating between 8 am and 11 pm.
Behavioural: Normal timing of food intake
No time restricted feeding |
| Outcomes |
Primary Outcome Measures :
HbA1c [ Time Frame: 12 weeks ]
Change in HbA1c between the intervention and control arms.
Secondary Outcome Measures:
Body weight [ Time Frame: 12 weeks ]
Change in body weight between the intervention and control arms.
Insulin sensitivity [ Time Frame: 12 weeks ]
Change insulin sensitivity assessed by OGTT between the intervention and control arms.
Diabetes medications [ Time Frame: 12 weeks ]
Change in diabetes medications between the intervention and control arms.
Inflammatory markers [ Time Frame: 12 weeks ]
Change in TNF‐alpha in pg/mL between the intervention and control arms.
Inflammatory markers [ Time Frame: 12 weeks ]
Change in IL‐10 in pg/mL between the intervention and control arms.
Inflammatory markers [ Time Frame: 12 weeks ]
Change in IL‐6 in pg/mL between the intervention and control arms.
Inflammatory markers [ Time Frame: 12 weeks ]
Change in IL‐18 in pg/mL between the intervention and control arms.
Inflammatory markers [ Time Frame: 12 weeks ]
Change in CRP in mg/L between the intervention and control arms.
Inflammatory markers [ Time Frame: 12 weeks ]
Change in adiponectin in µg/mL the intervention and control arms. |
| Starting date |
July 10, 2019 |
| Contact information |
Nicola.Guess@dasmaninstitute.org |
| Notes |
NCT04062773 |
