RecruitingRecruiting
Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)
NCT04869098 · University of Adelaide
In plain English
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Official title
Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release in Night ShIfT Workers (PROPENSITy)
About this study
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 days. No other advice will be given. 2) an identical mixed-nutrient drink matched for caloric content, taste and palatability consumed 1-1.5 hr prior to their main evening meal every day for 12 days(placebo). Conditions are separated by a 2-week washout period, during which participants will be encouraged to maintain their habitual diet and physical activity levels. Metabolic testing will be performed at baseline, and at the end of both conditions.
Eligibility criteria
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)
Study design
Enrollment target: 30 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2021-04-27
Estimated completion: 2026-07-31
Last updated: 2024-12-24
Interventions
Dietary Supplement: whey proteinDietary Supplement: Placebo
Primary outcomes
- • Glycaemic response (12 days (3 hours meal test))
Sponsor
University of Adelaide · other
Contacts & investigators
ContactAmy Hutchison, PhD · contact · amy.hutchison@adelaide.edu.au · 8128 4862
ContactLeonie Heilbronn, PhD · contact · leonie.heilbronn@adelaide.edu.au · 8128 4838
InvestigatorAmy T Hutchison, PhD · principal_investigator, University of Adelaide
All locations (1)
University of AdelaideRecruiting
Adelaide, South Australia, Australia