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

University of Adelaide

Status: Enrolling

Conditions: Shift-work Disorder; Type 2 Diabetes

Treatments: Dietary Supplement: Placebo; Dietary Supplement: whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT04869098

H-2020-131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Whey protein preload condition

Experimental group

Description:

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.

Treatment:

Dietary Supplement: whey protein

Placebo condition

Placebo Comparator group

Description:

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,

Treatment:

Dietary Supplement: Placebo