Impact of different low-calorie diets on glucose metabolism in shift workers with prediabetes or type 2 diabetes
A Randomized Study to Investigate the Effect of Low-calorie Diets With Different Macronutrient Composition and Macronutrient Distribution in Shift Workers With Prediabetes or Type 2 Diabetes and Overweight or Obesity.
This study is testing how three different low-calorie diets affect blood sugar and health in overweight shift workers with prediabetes or type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de Zaragoza Academic / other |
| Locations | 1 site (Zaragoza) |
| Trial ID | NCT06912555 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of three distinct low-calorie diets with varying macronutrient compositions on glucose metabolism and health outcomes in overweight or obese shift workers diagnosed with prediabetes or type 2 diabetes. The study will recruit 120 participants who will be randomly assigned to one of the three diet groups: a high-protein dinner, a low-protein dinner, or a normoproteic diet. Over a 12-week period, the trial will assess changes in body composition and metabolic health, aiming to identify effective dietary strategies for this at-risk population.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese shift workers with a BMI between 27.5 and 40 kg/m2 and diagnosed with prediabetes or type 2 diabetes.
Not a fit: Patients currently on antidiabetic medications other than stable metformin or DPP-4 inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide tailored dietary interventions to improve metabolic health in shift workers at risk for diabetes.
How similar studies have performed: Previous studies have shown that dietary interventions can positively impact metabolic health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index (BMI) ranging between 27.5 and 40 kg/m2. * Presence of prediabetes (fasting glucose between 100-125 mg/dL and/or glycated hemoglobin between 5.7 and 6.4%) or type 2 diabetes mellitus (fasting glucose ≥ 126 mg/dL and/or glycated hemoglobin ≥ 6.5% and/or currently taking metformin), based on the criteria of the American Diabetes Association. * Engaged in shift work, including night shifts, for at least 1 year and intending to maintain this schedule in the upcoming months. * Provide written informed consent for voluntary participation in the study after reviewing the participant information sheet and addressing any resulting queries. Exclusion Criteria: * Treatment with antidiabetic medications (oral or subcutaneous) or insulin in the last 2 months, except for stable use of metformin or Dipeptidyl peptidase 4 (DPP-4) inhibitors for a minimum of 6 months. * Treatment with lipid-lowering agents in an unstable manner for at least 6 months prior to study entry. * Regular consumption of functional foods such as phytosterols or red yeast rice, which have a significant effect on lipid or glucose metabolism, in an unstable manner for at least 6 months prior to study entry. * Presence of other chronic conditions that are not well-controlled and could interfere with study outcomes, such as cardiovascular disease, renal disease, or liver disease. * Presence of uncontrolled endocrine disorders, including hypothyroidism. * Use of medications that could interfere with lipid and/or glucose metabolism, unless taken stably throughout the study. * Consumption of sleep supplements, except for stable use for 6 months with the intention to continue stable use throughout the study. * Presence of any laboratory abnormalities that could affect study results. * Weight gain or loss of ≥ 5% in the last 3 months. * Use of vitamin supplements in an unstable manner for at least 6 months prior to study entry. * High intake of alcohol (\> 30 g of ethanol) on a regular basis. * Pregnancy or intention to become pregnant during the study. * Severe illness of any kind with a life expectancy of less than 1 year or that, in the investigators' judgment, limits uniform dietary intake throughout the study. * Any other circumstance that, in the investigators' judgment, would impede adequate adherence to the proposed nutritional intervention (e.g., frequent travel during the study, inability to attend visits due to personal or work-related circumstances, etc.).
Where this trial is running
Zaragoza
- Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Rocío Mateo-Gallego, PhD
- Email: rmateo@unizar.es
- Phone: +34 976 71 6818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.