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

NCT04869098 | Recruiting

• 1 other identifier: H-2020-131
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Shift-work Disorder

Outcome Measures

Primary Outcomes (1)

• Glycaemic response

  Change in glucose (AUC) following a standard breakfast

  12 days (3 hours meal test)

Secondary Outcomes (16)

• 24-hour glucose profiles

  12 days

• Glucose variability

  12 days

• Glucose variability

  12 days

• Glucose variability

  12 days

• GLP-1

  12 days (3 hours meal test)

Study Arms (2)

Whey protein preload condition

EXPERIMENTAL

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

Placebo condition

PLACEBO COMPARATOR

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

Interventions

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.

Whey protein preload condition

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.

Placebo condition

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Night shift workers (with a minimum of 6 months in their current shift work schedule)
• years
• BMI 28.0-35.0 kg/m2; waist circumference \> 80cm
• Weight stable in the past 6 months

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Adelaide: lead

Study Sites (1)

University of Adelaide

Adelaide, South Australia, Australia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Amy T Hutchison, PhD

  University of Adelaide

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Hutchison, PhD

CONTACT

8128 4862; amy.hutchison@adelaide.edu.au

Leonie Heilbronn, PhD

CONTACT

8128 4838; leonie.heilbronn@adelaide.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 3, 2021
• Study Start: April 27, 2021
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)