Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: whey protein, Placebo.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Shift-work Disorder. Basic parameters: 35 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of an Evening PROtein PrEload on Blood Glucose, Metabolic Health, and Gut Hormone Release in Night ShIfT Workers (PROPENSITy)
Overview
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- Glycaemic response [Time frame: 12 days (3 hours meal test)]
Secondary outcome measures (12)
- 24-hour glucose profiles [Time frame: 12 days]
- Glucose variability [Time frame: 12 days]
- Glucose variability [Time frame: 12 days]
- Glucose variability [Time frame: 12 days]
- GLP-1 [Time frame: 12 days (3 hours meal test)]
- GIP [Time frame: 12 days (3 hours meal test)]
- glucagon [Time frame: 12 days (3 hours meal test)]
- Insulin [Time frame: 12 days]
- Ghrelin [Time frame: 12 days (3 hours meal test)]
- PYY [Time frame: 12 days]
- Adiponectin [Time frame: 12 days]
- C-Reactive Protein (CRP) [Time frame: 12 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Australia · 1 center
- University of Adelaide — Adelaide
Identifiers
NCT: NCT04869098 · H-2020-131