Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001029886
Ethics application status
Approved
Date submitted
25/06/2021
Date registered
5/08/2021
Date last updated
2/02/2023
Date data sharing statement initially provided
5/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Break-Fast study: Effect of a protein-rich breakfast on autophagy in fasting healthy people.
Scientific title
The Break-Fast study: Effect of a protein-rich breakfast on autophagic flux in fasting healthy people.
Secondary ID [1] 304330 0
Nil known
Universal Trial Number (UTN)
U1111-1268-0236
Trial acronym
The Break-Fast Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autophagic flux in healthy subjects 322091 0
Condition category
Condition code
Diet and Nutrition 319809 319809 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a single-arm pre-post study that aims to measure the effect of a protein-rich breakfast on autophagic flux (i.e. a cell mechanism that cleanses the cells) in fasting healthy individuals.
After an overnight fast (12 hours, with permission to drink water), participants will attend a 1.5 hours intervention appointment at the clinical facility of the South Australian Health and Medical Research Institute for testing. Participants will be asked to refrain from strenuous exercise and alcohol the day before the test. They will arrive at 8 a.m. After collection of anthropometric information (weight, height, waist and hip circumference and blood pressure), a fasting blood sample will be drawn. Immediately after the blood collection, participants will be asked to consume a standardised whey protein isolate powder (30 g, 90% protein) diluted in skim milk (250 mL) in less than 5 min. The drink will be prepared and provided by a member of the clinical study research team, who will monitor that the drink is consumed entirely within the allocated 5 minutes. After a resting period of 60 min post drink consumption, a second blood collection will be performed. During the resting period, participants will be permitted water (but no other food or drinks) and will be asked to remain sedentary. Autophagic flux will be measured in the blood samples obtained from participants before and after consumption of the protein-rich drink.
Intervention code [1] 320688 0
Treatment: Other
Intervention code [2] 321149 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327676 0
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.
Timepoint [1] 327676 0
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).
Secondary outcome [1] 396204 0
Change in blood glucose levels (before and after a whey protein drink is consumed).
Timepoint [1] 396204 0
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).
Secondary outcome [2] 396332 0
Change in autophagy-related proteins in plasma, serum, whole blood and peripheral blood mononuclear cells (exploratory)
Timepoint [2] 396332 0
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).
Secondary outcome [3] 396333 0
Change in plasma hormones (exploratory)
Timepoint [3] 396333 0
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).
Secondary outcome [4] 396334 0
Change in plasma cytokines (exploratory)
Timepoint [4] 396334 0
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).
Secondary outcome [5] 396757 0
Change in plasma amino acids (exploratory)
Timepoint [5] 396757 0
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).
Secondary outcome [6] 396758 0
Change in plasma lipids (exploratory)
Timepoint [6] 396758 0
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).
Secondary outcome [7] 396759 0
Molecular cell damage (e.g. lipid oxidation, oxidative stress) will be measured in the plasma using commercially available assays.
Timepoint [7] 396759 0
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).
Secondary outcome [8] 407655 0
Change in protein synthesis (exploratory) by processing blood samples using an adapted version of the SUnSET method (Schmidt et.al 2009)
Timepoint [8] 407655 0
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).
Secondary outcome [9] 407656 0
Identification of molecules that correlate with autophagic flux in order to explore biomarker development (exploratory) using plasma and leukocytes isolated and stored.
Timepoint [9] 407656 0
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).
Secondary outcome [10] 407657 0
Investigation of autophagic flux and inflammatory markers (protein and gene expression) in monocyte-derived microglia-like cells (exploratory) using blood samples.
Timepoint [10] 407657 0
At 1 hour timepoint (one hour after the whey protein drink is consumed).

Eligibility
Key inclusion criteria
1. Aged between 20 and 50 years of age
2. BMI between 18.5 and 29.9 kg/m2
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The effect of the protein-rich drink on primary and secondary outcomes will be analysed using a linear regression model, including age, gender and body mass index as covariates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/03/2022
Actual
10/03/2022
Date of last participant enrolment
Anticipated
2/09/2022
Actual
2/09/2022
Date of last data collection
Anticipated
2/09/2022
Actual
2/09/2022
Sample size
Target
40
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 34239 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 308704 0
Other Collaborative groups
Name [1] 308704 0
Lysosomal Health in Aging group, Hopwood Centre for Neurobiology, SAHMRI
Country [1] 308704 0
Australia
Primary sponsor type
Individual
Name
Dr Timothy Sargeant
Address
Level 6 North
South Australian Health and Medical Research Institute (SAHMRI)
North Terrace
Adelaide, South Australia
5000
Country
Australia
Secondary sponsor category [1] 310100 0
None
Name [1] 310100 0
Address [1] 310100 0
Country [1] 310100 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308629 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 308629 0
Ethics committee country [1] 308629 0
Australia
Date submitted for ethics approval [1] 308629 0
30/10/2020
Approval date [1] 308629 0
22/02/2021
Ethics approval number [1] 308629 0
H-2021-024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111366 0
Dr Tim Sargeant
Address 111366 0
Hopwood Centre for Neurobiology
South Australian Health and Medical Research Institute
North Terrace, Adelaide
South Australia
5000
Country 111366 0
Australia
Phone 111366 0
+61 881284940
Fax 111366 0
Email 111366 0
[email protected]
Contact person for public queries
Name 111367 0
Tim Sargeant
Address 111367 0
Hopwood Centre for Neurobiology
South Australian Health and Medical Research Institute
North Terrace, Adelaide
South Australia
5000
Country 111367 0
Australia
Phone 111367 0
+61 881284940
Fax 111367 0
Email 111367 0
[email protected]
Contact person for scientific queries
Name 111368 0
Tim Sargeant
Address 111368 0
Hopwood Centre for Neurobiology
South Australian Health and Medical Research Institute
North Terrace, Adelaide
South Australia
5000
Country 111368 0
Australia
Phone 111368 0
+61 881284940
Fax 111368 0
Email 111368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study findings will be made available in a way so that no individual is identifiable without their consent.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Break-Fast study protocol: a single arm pre-post study to measure the effect of a protein-rich breakfast on autophagic flux in fasting healthy individuals.2022https://dx.doi.org/10.1186/s40795-022-00617-5
N.B. These documents automatically identified may not have been verified by the study sponsor.