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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04869098




Registration number
NCT04869098
Ethics application status
Date submitted
26/04/2021
Date registered
3/05/2021
Date last updated
27/03/2023

Titles & IDs
Public title
Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)
Scientific title
Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release in Night ShIfT Workers (PROPENSITy)
Secondary ID [1] 0 0
H-2020-131
Universal Trial Number (UTN)
Trial acronym
PROPENSITy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Shift-work Disorder 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - whey protein
Treatment: Other - Placebo

Experimental: Whey protein preload condition - Participants will consume 30 g whey protein isolate powder (dissolved in water) 1-1.5 hr prior to their main evening meal every day for 12 days.

Placebo comparator: Placebo condition - Participants will consume an energy-matched mixed-nutrient placebo drink 1-1.5 hr prior to their main evening meal every day for 12 days,


Treatment: Other: whey protein
Protein drink containing 30g whey protein isolate powder (dissolved in water) consumed 1-1.5 hr prior to their main evening meal every day for 12 days, No other advice will be given.

Treatment: Other: Placebo
Energy-matched mixed-nutrient placebo drink consumed 1-1.5 hr prior to their main evening meal every day for 12 days. No other advice will be given.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glycaemic response
Timepoint [1] 0 0
12 days (3 hours meal test)
Secondary outcome [1] 0 0
24-hour glucose profiles
Timepoint [1] 0 0
12 days
Secondary outcome [2] 0 0
Glucose variability
Timepoint [2] 0 0
12 days
Secondary outcome [3] 0 0
Glucose variability
Timepoint [3] 0 0
12 days
Secondary outcome [4] 0 0
Glucose variability
Timepoint [4] 0 0
12 days
Secondary outcome [5] 0 0
GLP-1
Timepoint [5] 0 0
12 days (3 hours meal test)
Secondary outcome [6] 0 0
GIP
Timepoint [6] 0 0
12 days (3 hours meal test)
Secondary outcome [7] 0 0
glucagon
Timepoint [7] 0 0
12 days (3 hours meal test)
Secondary outcome [8] 0 0
Insulin
Timepoint [8] 0 0
12 days
Secondary outcome [9] 0 0
Ghrelin
Timepoint [9] 0 0
12 days (3 hours meal test)
Secondary outcome [10] 0 0
PYY
Timepoint [10] 0 0
12 days
Secondary outcome [11] 0 0
Adiponectin
Timepoint [11] 0 0
12 days
Secondary outcome [12] 0 0
C-Reactive Protein (CRP)
Timepoint [12] 0 0
12 days
Secondary outcome [13] 0 0
Blood lipids
Timepoint [13] 0 0
12 days
Secondary outcome [14] 0 0
Blood pressure
Timepoint [14] 0 0
12 days
Secondary outcome [15] 0 0
Resting metabolic rate
Timepoint [15] 0 0
12 days
Secondary outcome [16] 0 0
respiratory quotient
Timepoint [16] 0 0
12 days

Eligibility
Key inclusion criteria
* Female
* Night shift workers (with a minimum of 6 months in their current shift work schedule)
* 35-65 years
* BMI 28.0-35.0 kg/m2; waist circumference > 80cm
* Weight stable in the past 6 months
Minimum age
35 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Those working standard day time hours only, or those who work less than three to four night shifts per fortnight on average
* Personal history and/or diagnosis of: diabetes, cancer, major psychiatric disorders, liver disease, gastro-intestinal surgery or disease (including malabsorption), eating disorders, anaemia, insomnia or cardiovascular disease, and/or any other condition deemed unstable by the study physician
* Taking medications known to alter body composition or metabolism, including (but not limited to): any medication used to lower blood glucose or antidiabetic medications (metformin, sulfonylureas, Glucagon-like peptide-1 (GLP-1) analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins']), medications affecting weight, appetite or gut motility (i.e. diuretics, domperidone, cisapride, orlistat, phentermine, topiramate)
* Participants who are taking stable doses (i.e. > 12 months) of androgenic medications (i.e. testosterone) or SSRI's will not be excluded. Personal history/diagnosis (self-reported) of diabetes (type 1 or 2), major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders), gastrointestinal disorders, haematological disorders (i.e. thalassemia, iron-deficiency anaemia) insomnia, or any other medical condition, deemed unstable by the study physician
* Pregnant, planning a pregnancy or breastfeeding
* Those who have lost or gained >5% of body weight in the last 6 months
* Those who consume four or more standard drinks on a single occasion at a 'daily or almost daily' occurrence
* current smokers of cigarettes/marijuana/e-cigarettes/vaporisers
* 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
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare the effects of a whey protein supplement or a placebo consumed before the evening meal on health outcomes in night shift workers.
Trial website
https://clinicaltrials.gov/study/NCT04869098
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amy T Hutchison, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Hutchison, PhD
Address 0 0
Country 0 0
Phone 0 0
8128 4862
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04869098