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

Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release 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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Shift-work Disorder
• Intervention / Treatment: Dietary supplement: whey protein; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Hutchison, PhD; Phone Number: 8128 4862; Email: amy.hutchison@adelaide.edu.au
• Study Contact Backup: Name: Leonie Heilbronn, PhD; Phone Number: 8128 4838; Email: leonie.heilbronn@adelaide.edu.au

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia
      • Recruiting
      • University of Adelaide
      • Contact: Amy T Hutchison, PhD; Phone Number: +61 8128 4862; Email: amy.hutchison@adelaide.edu.au
      • Principal Investigator: Amy T Hutchison, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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 Comparator: 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,	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycaemic response	Change in glucose (AUC) following a standard breakfast	12 days (3 hours meal test)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour glucose profiles	Change in 24-hour glucose profiles assessed by continuous glucose monitoring	12 days
Glucose variability	Change in 24-hour glucose variability (as SD, standard deviation) assessed by continuous glucose monitoring	12 days
Glucose variability	Change in 24-hour glucose variability (as CV, coefficients of variation) assessed by continuous glucose monitoring	12 days
Glucose variability	Change in 24-hour glucose variability (as MAGE, mean amplitude of gylcaemic excursions) assessed by continuous glucose monitoring	12 days
GLP-1	Change in GLP-1 (AUC) following a standard breakfast	12 days (3 hours meal test)
GIP	Change in GIP (AUC) following a standard breakfast	12 days (3 hours meal test)
glucagon	Change in glucagon (AUC) following a standard breakfast	12 days (3 hours meal test)
Insulin	Change in fasting and postprandial insulin following a standard breakfast	12 days
Ghrelin	Change in ghrelin (AUC) following a standard breakfast	12 days (3 hours meal test)
PYY	Change in YY (AUC) following a standard breakfast	12 days
Adiponectin	Change in fasting adiponectin	12 days
C-Reactive Protein (CRP)	Change in fasting CRP	12 days
Blood lipids	Changes in blood lipid profile (total cholesterol, HDL-, LDL-cholesterol and triglycerides)	12 days
Blood pressure	Changes in systolic blood pressure and diastolic blood pressure	12 days
Resting metabolic rate	Changes in resting metabolic rate	12 days
respiratory quotient	Changes in respiratory quotient	12 days

Collaborators and Investigators

• Sponsor: University of Adelaide
• Investigators: Principal Investigator: Amy T Hutchison, PhD, University of Adelaide

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: H-2020-131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No