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Clinical Trials in Australia / NCT04869098
Recruiting Not applicable

Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)

NCT04869098 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2021-04-27
Last updated
2024-12-24

Condition(s) studied

Type 2 DiabetesShift-work Disorder

Investigational drug(s) / intervention(s)

whey proteinPlacebo

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
35 Years
Max age
65 Years
Healthy volunteers
Accepted
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 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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Adelaide Adelaide South Australia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04869098 on ClinicalTrials.gov ↗ ← All trials in Australia