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NCT05769335Completed

Calories or Time Restriction to Alter Biomarkers of Aging and Diabetes

The Effects of Caloric Restriction Plus Time Restriction on Glycemia, Circadian Rhythms and Cardiometabolic Health

Source: ClinicalTrials.gov · Last updated 9 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
114 (actual)
First submitted
1 Mar 2023
Start date
15 Mar 2023
Primary completion date
10 Dec 2024
Lead sponsor
University of Adelaide
Diseases
Obesity
NCT number
NCT05769335

What you commit to

  • Study type: Interventional
  • Participants enrolled: 114
  • From 15 Mar 2023 to the primary completion date, 10 Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • previous or planned gastro-intestinal surgery (including bariatric surgery)
  • Previous myocardial infarction or significant cardiac event ≤ 6 months prior to screening
  • Previous cerebrovascular event ≤ 12 months prior to screening
  • do not own, or are not comfortable using, a smart phone and applications
    • Currently taking the following medications:
  • Diuretics (i.e. frusemide, thiazides) or combination blood pressure medications containing a diuretic
  • Anti-epileptic medications (i.e. pregabalin and gabapentin)
  • Some serotonin and norepinephrine reuptake inhibitors (i.e. vortioxetine, mirtazapine and venlafaxine)
  • Antipsychotic medications
  • Opioid medications unless combined with paracetamol in a single formulation and used occasionally on as needs basis

Other illness

  • 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)
  • 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
  • Congestive heart failure (NYHA stage 2 or above)
  • Any autoimmune disease (i.e. rheumatoid arthritis)
  • Coeliac disease
  • Score less than 12 of the Australian Diabetes (AUSD) risk assessment tool
  • Other dietary restrictions including vegans, gluten or nut allergies

Lab values

  • 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

Other

  • A personal history/diagnosis (self-reported) of:
  • insomnia
  • obstructive sleep apnea
  • 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
  • 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)
  • affecting weight, appetite or gut motility, including, but not limited to semaglutide, domperidone, cisapride, orlistat, phentermine, topiramate.
  • Beta-blockers
  • Glucocorticoids
  • Tricyclic antidepressants
  • Regular use of benzodiazepines or other sleep aids, including melatonin

Who the study is looking for

  • Overweight or obesity (BMI 25.1 - 44.9 kg/m2)
  • Elevated waist circumference (race specific),
  • Elevated fasting blood glucose (\>5.6 mmol/L).

Age in the registry: 35 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
South Australian Health and Medical Research Institute / The University of Adelaide
Coordinator of this site? Confirm its status
AdelaideAustraliaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.