NCT04869098Recruiting
Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)
Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release in Night ShIfT Workers (PROPENSITy)
Source: ClinicalTrials.gov · Last updated 24 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 26 Apr 2021
- Start date
- 27 Apr 2021
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- University of Adelaide
- Diseases
- Type 2 diabetes
- NCT number
- NCT04869098
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 27 Apr 2021 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
Lab values
- 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)
Other
- Those working standard day time hours only, or those who work less than three to four night shifts per fortnight on average
- 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)
Who the study is looking for
- 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
Age in the registry: 35 years to 65 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Adelaide Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.