The Break-Fast study: Effect of a protein-rich breakfast on autophagy in fasting healthy people.

Not Applicable

Completed

• Conditions: Diet and Nutrition - Other diet and nutrition disorders; Autophagic flux in healthy subjects

• Registration Number: ACTRN12621001029886
• Lead Sponsor: Dr Timothy Sargeant

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-05
• Study Completion: 2022-09-02
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Aged between 20 and 50 years of age
2. BMI between 18.5 and 29.9 kg/m2

Exclusion Criteria

1. 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), major psychiatric disorders (schizophrenia, addiction, eating disorders, major depressive disorder), neurological disorders, dementia, and/or any other condition deemed likely to affect the results by the study principal investigator.
2. Taking any medications that, in the opinion of the investigator, might change autophagic activity; including, but not restricted to, medications that change body composition or metabolism (e.g. medications used to lower blood glucose, antidiabetic medications), anti-inflammatory medications, medications that change brain function (e.g. antidepressant medications, mood stabilisers, lithium), medications used in the treatment of cancer or cardiovascular disorders. Female participants taking hormonal contraceptive will not be excluded from the study. If they have a regular menstrual cycle, we will ask that they attend the study appointment between day 1 and day 10 of their menstrual cycle.
3. Current alcohol and/or substance use disorder.
4. Lactose intolerance (except if managed by medication eg. Lacteeze).
5. Vegan.
6. Allergies preventing consumption of study product.
7. Current smoker.
8. Pregnant or breastfeeding women or women planning a pregnancy.
9. Women who have been through menopause.
10. Any lifestyle (e.g. physical activity, dietary habits) and/or change in lifestyle deemed likely to affect the results by the study principal investigator.
11. Anyone who is unable to comprehend the study protocol (i.e. due to English language or cognitive difficulties).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in autophagic flux (before and after a whey protein drink is consumed), assessed by measuring the amount of the autophagic cargo LC3 (with or without the autophagic inhibitor chloroquine) in peripheral blood mononuclear cells by ELISA.[Baseline (after a 12 hour overnight fast and before a whey protein drink is consumed) and 1 hour (one hour after the whey protein drink is consumed).]