Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)
NCT ID: NCT04869098
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-04-27
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Whey protein preload condition
Participants will consume 30 g whey protein isolate powder (dissolved in water) 1-1.5 hr prior to their main evening meal every day for 12 days.
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 condition
Participants will consume an energy-matched mixed-nutrient placebo drink 1-1.5 hr prior to their main evening meal every day for 12 days,
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
35 Years
65 Years
FEMALE
Yes
Sponsors
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University of Adelaide
OTHER
Responsible Party
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A/Prof Leonie Heilbronn
A/Prof
Principal Investigators
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Amy T Hutchison, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Adelaide
Locations
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University of Adelaide
Adelaide, South Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Amy T Hutchison, PhD
Role: primary
Amy T Hutchison, PhD
Role: backup
Other Identifiers
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H-2020-131
Identifier Type: -
Identifier Source: org_study_id