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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Type 2 Diabetes, Shift-work Disorder

In brief

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.

Key facts

Study ID

NCT04869098

Run by

University of Adelaide

People needed

30

Starts

2021-04-27

Expected to finish

2026-07-31

Last updated by the study team

2024-12-24

Who can join

Age: 35 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Adelaide — Adelaide, South Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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