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Calories or Time Restriction to Alter Biomarkers of Aging and Diabetes

RECRUITING

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.

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)
  • Exclusion criteria

  • 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
  • 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
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    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

    Study type

    BASIC_SCIENCE

    phase

    Phase

      NA

    trial

    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

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    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/ArmIntervention/Treatment
    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.
    OTHER: eCR
    • Eating time window from 8:00 to 16:00
    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.
    OTHER: dCR
    • Eating time window from 12:00 to 20:00
    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: CR
    • Eating time window from 8:00 to 20:00

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Glucose area under curve (AUC) after 3 mealsChange in glucose AUC after 3 meals8 weeks

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    24 h glucose on ward (by continuous glucose monitor (CGM)Change in 24 h glucose on ward by CGM8 weeks
    Insulin AUCsChange in insulin AUC after 3 meals8 weeks
    Insulin sensitivity (calculated by Matsuda index where a higher score means greater insulin sensitivity)Change in insulin sensitivity8 weeks
    Fasting glucoseChange in fasting glucose8 weeks
    Fasting insulinChange in fasting insulin8 weeks
    C-reactive protein (CRP)Change in hs-CRP8 weeks
    Body weightChange in body weight8 weeks
    Physical activity by activity monitorChange in step count8 weeks
    Adherence to the prescribed eating window (+/- 1 hour) by smart phone applicationAdherence to the prescribed eating window(+/- 1 hour) by smart phone application8 weeks
    Change in fat massChange in fat mass by bio-electrical impedance analysis8 weeks

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Calories or Time Restriction to Alter Biomarkers of Aging and Diabetes

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