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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05769335




Registration number
NCT05769335
Ethics application status
Date submitted
1/03/2023
Date registered
15/03/2023
Date last updated
27/03/2023

Titles & IDs
Public title
Calories or Time Restriction to Alter Biomarkers of Aging and Diabetes
Scientific title
The Effects of Caloric Restriction Plus Time Restriction on Glycemia, Circadian Rhythms and Cardiometabolic Health
Secondary ID [1] 0 0
H-2022-199
Universal Trial Number (UTN)
Trial acronym
OMIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - eCR
Other interventions - dCR
Other interventions - CR

Experimental: early calorie restriction (eCR) - Individuals will be provided with menus prescribed at 70% of calculated energy requirements and instructed to eat within 8 h/day (e.g. 8:00 - 16:00) every day for 8 weeks, except 1 evening meal per week off the program (i.e. Saturday nights) to assist with overall adherence.

Experimental: delayed calorie restriction (dCR) - Individuals will be provided with menus prescribed at 70% of calculated energy requirements and instructed to eat within 8 h/day (e.g 12:00 - 20:00) every day for 8 weeks, except 1 evening meal per week off the program (i.e. Saturday nights) to assist with overall adherence.

Active comparator: Calorie restriction (CR) - Individuals will be provided with menus prescribed at 70% of calculated energy requirements every day for 8 weeks. The menus will encourage breakfast and after-dinner consumption of the snack to eat over at least a 12 hour time frame per day (e.g. 8:00 - 20:00), except 1 evening meal per week off the program (i.e. Saturday nights) to assist with overall adherence.


Other interventions: eCR
Eating time window from 8:00 to 16:00

Other interventions: dCR
Eating time window from 12:00 to 20:00

Other interventions: CR
Eating time window from 8:00 to 20:00
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glucose area under curve (AUC) after 3 meals
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
24 h glucose on ward (by continuous glucose monitor (CGM)
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Insulin AUCs
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Insulin sensitivity (calculated by Matsuda index where a higher score means greater insulin sensitivity)
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Fasting glucose
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Fasting insulin
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
C-reactive protein (CRP)
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Body weight
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Physical activity by activity monitor
Timepoint [8] 0 0
8 weeks
Secondary outcome [9] 0 0
Adherence to the prescribed eating window (+/- 1 hour) by smart phone application
Timepoint [9] 0 0
8 weeks
Secondary outcome [10] 0 0
Change in fat mass
Timepoint [10] 0 0
8 weeks

Eligibility
Key inclusion criteria
* Overweight or obesity (BMI 25.1 - 44.9 kg/m2)
* Elevated waist circumference (race specific),
* Elevated fasting blood glucose (>5.6 mmol/L).
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A personal history/diagnosis (self-reported) of:

* diabetes (type 1 or 2)
* major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders)
* gastrointestinal disorders/disease (including malabsorption)
* haematological disorders (i.e. thalassemia, iron-deficiency anaemia)
* insomnia
* obstructive sleep apnea
* night eating syndrome
* diagnosis or treatment of cancer in the past 3 years (excluding non-melanoma skin cancer)
* significant liver or kidney diseases that require ongoing medical care
* previous or planned gastro-intestinal surgery (including bariatric surgery)
* Congestive heart failure (NYHA stage 2 or above)
* Previous myocardial infarction or significant cardiac event = 6 months prior to screening
* Previous cerebrovascular event = 12 months prior to screening
* Any autoimmune disease (i.e. rheumatoid arthritis)
* Coeliac disease
* Score less than 12 of the Australian Diabetes (AUSD) risk assessment tool
* Do not eat for a 12 hour window each day for 5 or more days per week
* Have extreme or restricted patterns of eating (i.e. following an intermittent fasting diet) or already engage in CR
* Other dietary restrictions including vegans, gluten or nut allergies
* Night shift-workers (>3 shifts per month)
* pregnant, planning a pregnancy or currently breastfeeding
* those who have lost or gained >5% of body weight in the last 6 months
* donated blood in past 3 months
* current smokers of cigarettes/marijuana/e-cigarettes/vaporisers
* anyone unable to comprehend the study protocol or provide informed consent (i.e. due to English language or cognitive difficulties)
* do not own, or are not comfortable using, a smart phone and applications

Currently taking the following medications:

* Anti-diabetic medications that lower blood glucose including, but not limited to: SGLT2 inhibitors, metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e. semaglutide], thiazolidinediones
* affecting weight, appetite or gut motility, including, but not limited to semaglutide, domperidone, cisapride, orlistat, phentermine, topiramate.
* Diuretics (i.e. frusemide, thiazides) or combination blood pressure medications containing a diuretic
* Beta-blockers
* Glucocorticoids
* Anti-epileptic medications (i.e. pregabalin and gabapentin)
* Tricyclic antidepressants
* Some serotonin and norepinephrine reuptake inhibitors (i.e. vortioxetine, mirtazapine and venlafaxine)
* Regular use of benzodiazepines or other sleep aids, including melatonin
* Antipsychotic medications
* Opioid medications unless combined with paracetamol in a single formulation and used occasionally on as needs basis

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
South Australian Health and Medical Research Institute / The University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Salk Institute for Biological Studies
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05769335
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie Heilbronn, PhD.
Address 0 0
The University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Leonie Heilbronn, PhD.
Address 0 0
Country 0 0
Phone 0 0
+61424187880
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05769335