Status:
RECRUITING
Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)
Lead Sponsor:
University of Adelaide
Conditions:
Type 2 Diabetes
Shift-work Disorder
Eligibility:
FEMALE
35-65 years
Phase:
NA
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.
Detailed Description
Participants are assigned in random order to two conditions, for 12 days each. The interventions are 1) a 30g whey protein preload consumed 1-1.5 hr prior to their main evening meal every day for 12 d...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04869098
Start Date
April 27 2021
End Date
July 31 2026
Last Update
December 24 2024
Active Locations (1)
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1
University of Adelaide
Adelaide, South Australia, Australia