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

Type 2 Diabetes Clinical Trial

— PROPENSITy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04869098
• Other study ID #: H-2020-131
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2023
• Source: University of Adelaide
• Contact: Amy Hutchison, PhD
• Phone: 8128 4862
• Email: amy.hutchison[@]adelaide.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Shift-work Disorder
• Type 2 Diabetes

Intervention

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
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.

Locations

Country	Name	City	State
Australia	University of Adelaide	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

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