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

RECRUITING

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.

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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.

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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)

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Eligibility

Age eligible for study : 35 and older

Healthy volunteers accepted : Yes

Gender eligible for study: Female

Things to know

Study dates

Study start: 2021-04-27

Primary completion: 2024-07-31

Study completion finish: 2024-07-31

Study type

PREVENTION

Phase

Trial ID

NCT04869098

Intervention or treatment

DIETARY_SUPPLEMENT: whey protein

DIETARY_SUPPLEMENT: Placebo

Conditions

• Type 2 Diabetes
• Shift-work Disorder

Condition: Type 2 Diabetes, Shift-work Disorder
DIETARY_SUPPLEMENT: whey protein and other drugs
Adelaide, South Australia, Australia
Sponsor: University of Adelaide

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

University of Adelaide

Research sites nearby

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University of Adelaide
Adelaide, South Australia, Australia

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 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

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

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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References

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