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New treatment option for Type 2 Diabetes
Official title Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)
ClinicalTrials.gov ID: NCT04869098
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 65, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join 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...
- Taking medications known to alter body composition or metabolism, including (but not limited to): any medication used to lower blood glucose or...
- Participants who are taking stable doses (i.e. \> 12 months) of androgenic medications (i.e. testosterone) or SSRI's will not be excluded. Personal...
- Pregnant, planning a pregnancy or breastfeeding
- Those who have lost or gained \>5% of body weight in the last 6 months
See the full eligibility 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
- 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 35 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.