Calories or Time Restriction to Alter Biomarkers of Aging and Diabetes (NCT05769335) | Clinical Trial Compass
CompletedNot Applicable
Calories or Time Restriction to Alter Biomarkers of Aging and Diabetes
Australia114 participantsStarted 2023-03-15
Plain-language 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.
Who can participate
Age range35 Years – 75 Years
SexALL
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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:
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 pregnanc…