Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-65
SponsorUniversity of Adelaide

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • whey protein

    Dietary supplement

    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

    Dietary supplement

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Whey protein preload conditionExperimental treatment 1 intervention
Group B: Placebo conditionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glycaemic response

Change in glucose (AUC) following a standard breakfast

Time frame
12 days (3 hours meal test)

Secondary outcomes

1

24-hour glucose profiles

Change in 24-hour glucose profiles assessed by continuous glucose monitoring

Time frame
12 days
2

Glucose variability

Change in 24-hour glucose variability (as SD, standard deviation) assessed by continuous glucose monitoring

Time frame
12 days
3

Glucose variability

Change in 24-hour glucose variability (as CV, coefficients of variation) assessed by continuous glucose monitoring

Time frame
12 days
4

Glucose variability

Change in 24-hour glucose variability (as MAGE, mean amplitude of gylcaemic excursions) assessed by continuous glucose monitoring

Time frame
12 days

Other outcomes

Sponsors and contacts

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