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NCT Number: NCT04869098

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

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.

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Key information

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Adelaide

Adelaide, South Australia, Australia

Location status: Recruiting

Location contact

Amy T Hutchison, PhD

CONTACT

[email protected]

+61 8128 4862

Amy T Hutchison, PhD

CONTACT

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Glycaemic response

    Time frame: 12 days (3 hours meal test)

    Change in glucose (AUC) following a standard breakfast

Secondary outcomes

  1. 24-hour glucose profiles

    Time frame: 12 days

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

  2. Glucose variability

    Time frame: 12 days

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

  3. Glucose variability

    Time frame: 12 days

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

  4. Glucose variability

    Time frame: 12 days

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

  5. GLP-1

    Time frame: 12 days (3 hours meal test)

    Change in GLP-1 (AUC) following a standard breakfast

  6. GIP

    Time frame: 12 days (3 hours meal test)

    Change in GIP (AUC) following a standard breakfast

  7. glucagon

    Time frame: 12 days (3 hours meal test)

    Change in glucagon (AUC) following a standard breakfast

  8. Insulin

    Time frame: 12 days

    Change in fasting and postprandial insulin following a standard breakfast

  9. Ghrelin

    Time frame: 12 days (3 hours meal test)

    Change in ghrelin (AUC) following a standard breakfast

  10. PYY

    Time frame: 12 days

    Change in YY (AUC) following a standard breakfast

  11. Adiponectin

    Time frame: 12 days

    Change in fasting adiponectin

  12. C-Reactive Protein (CRP)

    Time frame: 12 days

    Change in fasting CRP

  13. Blood lipids

    Time frame: 12 days

    Changes in blood lipid profile (total cholesterol, HDL-, LDL-cholesterol and triglycerides)

  14. Blood pressure

    Time frame: 12 days

    Changes in systolic blood pressure and diastolic blood pressure

  15. Resting metabolic rate

    Time frame: 12 days

    Changes in resting metabolic rate

  16. respiratory quotient

    Time frame: 12 days

    Changes in respiratory quotient

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Hutchison, PhD

CONTACT

[email protected]

8128 4862

Leonie Heilbronn, PhD

CONTACT

[email protected]

8128 4838

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Registry information

Official study title

Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release in Night ShIfT Workers (PROPENSITy)

Acronym: PROPENSITy

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
May 3, 2021
Registry last updated
Dec 24, 2024

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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