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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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)
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: FEMALE
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
PREVENTION
Phase
- NA
Study ID
NCT04869098
Intervention or treatment
DIETARY_SUPPLEMENT: whey protein
DIETARY_SUPPLEMENT: Placebo
Conditions
- Type 2 Diabetes
- Shift-work Disorder
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
University of Adelaide
Select from list below to view details:
University of Adelaide
Adelaide, South Australia, Australia
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Who is running the clinical trial?
University of Adelaide
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Whey protein preload condition
| Dietary Supplement: whey protein |
PLACEBO_COMPARATOR: Placebo condition
| Dietary Supplement: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic response | Change in glucose (AUC) following a standard breakfast | 12 days (3 hours meal test) |
Secondary Outcome
| 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 |
References
Clinical Trials Gov: Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)Other trials to consider
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