Effect of Nutritional INterventions on Autophagy (The NINA Study)
- Conditions
- Autophagic flux in healthy subjectsMetabolic and Endocrine - Normal metabolism and endocrine development and functionInflammatory and Immune System - Normal development and function of the immune system
- Registration Number
- ACTRN12623000260628
- Lead Sponsor
- Dr Timothy Sargeant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 61
1, Aged between 20 and 50 years of age
2. BMI between 18.5 and 29.9 kg/m2
1. Diagnosis or evidence of neurodegenerative disorder such as Alzheimer’s disease.
2. Any co-morbidities that are likely to change the activity of the lysosomal system, such as cancer, diabetes, cardiovascular disease/conditions (stroke, heart attack, high blood pressure), renal or liver disease, hemoglobin disorder or anaemia, gastrointestinal surgery or disease, major psychiatric disorders (schizophrenia, addiction, eating disorders, unstable major depressive disorder), neurological disorders, and/or any other condition deemed likely to affect the results by the study principal investigator.
3. Taking any medications that, in the opinion of the investigator, might change autophagic activity; including, but not restricted to, chronic medications or supplements that change appetite, body composition or metabolism (e.g. medications used to lower blood glucose, antidiabetic medications), anti-inflammatory medications, medications used in the treatment of cancer or cardiovascular disorders.
4. Female participants taking hormonal contraceptive will not be excluded from the study. It is preferable but not essential that women who have a menstrual cycle attend the M1 baseline study appointment between day 1 and day 10 of their menstrual cycle. Date of first day of menstrual cycle will be documented as well as cycle length in days at both Screening Visit and Metabolic Visits.
5. Anyone who is not weight stable (lost or gained > 5% body weight in the last 3 months).
6. Current alcohol abuse (>14 standard drinks/week) and/or substance use disorder.
7. Current smoker.
8. Vegan.
9. Lactose intolerance.
10. Pregnant or breastfeeding women or women planning a pregnancy.
11. Women who have been through menopause or peri-menopausal.
12. Self-reported dietary practice or restriction that may affect autophagy (including calorie restriction, intermittent fasting and ketogenic diets).
13. Self-reported high consumption of protein or supplements.
14. Anyone who has an eating disorder, food allergies or practices that are likely to interfere with compliance (eg. coeliac, gluten intolerance, and nut allergies).
15. Anyone who is unable to comprehend the study protocol (i.e. due to English language or cognitive difficulties).
16. Anyone with a pacemaker or other internal electronic medical devices.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in autophagic flux between an average macronutrient diet compared to altered macronutrient diet (randomly assigned crossover design). Assessed by measuring the amount of the autophagic cargo LC3 (with or without the lysosome inhibitor chloroquine) in peripheral blood mononuclear cells by ELISA.[ After 4 weeks adherence to diet 1 and after 4 weeks adherence to diet 2 (12 hour overnight fasted blood samples).]
- Secondary Outcome Measures
Name Time Method