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Calories or Time Restriction to Alter Biomarkers of Aging and Diabetes
Type 2 diabetes and cardiovascular disease are an increasing problem in Australia and around the world, and are partly linked to increased rates of obesity, together with sedentary lifestyles. This study will compare caloric restriction (CR) diets that restrict the amount of food that is eaten with CR diets that also restrict the time that the food is eaten, to either early or late in the day, on risk factors for type 2 diabetes and cardiovascular diseases over 2 months.
Study details:
In a parallel groups design, a total of 114 individuals will be recruited. After a two-week lead in and collection of data from activity monitors and continuous glucose monitors, plus a 28 hour (h) metabolic ward in-patient stay, participants will be randomised into one of three groups (eCR, 8-hour early time restriction + calorie restriction (e. g.
8:00-16:00); dCR, 8-hour delayed time restriction + calorie restriction (e. g. 12:00-20:00); CR, caloric restriction (\>12 hour eating window (e.
g. 8:00-20:00). All participants will receive individualised menus and foods that will be delivered to their homes by a supermarket delivery service at energy balance for 1 week (baseline) and at 70% of energy balance for a further 8 weeks.
Repeat assessment occurs from 6-8 weeks with the final metabolic ward stay at 8-weeks to assess changes in primary and secondary outcomes.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 35 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-03-15
Primary completion: 2025-10-01
Study completion finish: 2025-12-01
Study type
BASIC_SCIENCE
Phase
NA
Trial ID
NCT05769335
Intervention or treatment
OTHER: eCR
OTHER: dCR
OTHER: CR
Conditions
- • Obesity
Find a site
Closest Location:
South Australian Health and Medical Research Institute / The University of Adelaide
Research sites nearby
Select from list below to view details:
South Australian Health and Medical Research Institute / The University of Adelaide
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: early calorie restriction (eCR)
| OTHER: eCR
|
EXPERIMENTAL: delayed calorie restriction (dCR)
| OTHER: dCR
|
ACTIVE_COMPARATOR: Calorie restriction (CR)
| OTHER: CR
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Glucose area under curve (AUC) after 3 meals | Change in glucose AUC after 3 meals | 8 weeks |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
24 h glucose on ward (by continuous glucose monitor (CGM) | Change in 24 h glucose on ward by CGM | 8 weeks |
Insulin AUCs | Change in insulin AUC after 3 meals | 8 weeks |
Insulin sensitivity (calculated by Matsuda index where a higher score means greater insulin sensitivity) | Change in insulin sensitivity | 8 weeks |
Fasting glucose | Change in fasting glucose | 8 weeks |
Fasting insulin | Change in fasting insulin | 8 weeks |
C-reactive protein (CRP) | Change in hs-CRP | 8 weeks |
Body weight | Change in body weight | 8 weeks |
Physical activity by activity monitor | Change in step count | 8 weeks |
Adherence to the prescribed eating window (+/- 1 hour) by smart phone application | Adherence to the prescribed eating window(+/- 1 hour) by smart phone application | 8 weeks |
Change in fat mass | Change in fat mass by bio-electrical impedance analysis | 8 weeks |
Frequently Asked Questions
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