University of Adelaide
Adelaide, South Australia, Australia
Location status: Recruiting
NCT Number: NCT04869098
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.
Interested in participating?
Request Info35 year–65 year
Female
Interventional
Not applicable
Adelaide, South Australia, Australia
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 12 days (3 hours meal test)
Change in glucose (AUC) following a standard breakfast
Time frame: 12 days
Change in 24-hour glucose profiles assessed by continuous glucose monitoring
Time frame: 12 days
Change in 24-hour glucose variability (as SD, standard deviation) assessed by continuous glucose monitoring
Time frame: 12 days
Change in 24-hour glucose variability (as CV, coefficients of variation) assessed by continuous glucose monitoring
Time frame: 12 days
Change in 24-hour glucose variability (as MAGE, mean amplitude of gylcaemic excursions) assessed by continuous glucose monitoring
Time frame: 12 days (3 hours meal test)
Change in GLP-1 (AUC) following a standard breakfast
Time frame: 12 days (3 hours meal test)
Change in GIP (AUC) following a standard breakfast
Time frame: 12 days (3 hours meal test)
Change in glucagon (AUC) following a standard breakfast
Time frame: 12 days
Change in fasting and postprandial insulin following a standard breakfast
Time frame: 12 days (3 hours meal test)
Change in ghrelin (AUC) following a standard breakfast
Time frame: 12 days
Change in YY (AUC) following a standard breakfast
Time frame: 12 days
Change in fasting adiponectin
Time frame: 12 days
Change in fasting CRP
Time frame: 12 days
Changes in blood lipid profile (total cholesterol, HDL-, LDL-cholesterol and triglycerides)
Time frame: 12 days
Changes in systolic blood pressure and diastolic blood pressure
Time frame: 12 days
Changes in resting metabolic rate
Time frame: 12 days
Changes in respiratory quotient
Contact information is provided by the study sponsor or research team.
Amy Hutchison, PhD
CONTACT
Leonie Heilbronn, PhD
CONTACT
University of Adelaide
Other
Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release in Night ShIfT Workers (PROPENSITy)
Acronym: PROPENSITy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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