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.

Last updated: March 31, 2025
Sponsor: Universidad de Zaragoza
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes And Hypertension

Diabetes Mellitus, Type 2

Treatment

Diet

Clinical Study ID

NCT06912555
PI23/558
  • Ages > 18
  • All Genders

Study Summary

Background and Aims: Shift work, particularly involving night shifts, is associated with increased risk of metabolic disturbances such as type 2 diabetes mellitus (T2DM). Thus, it is important to explore mechanisms underlying this deleteroius effect and strategies that could prevent or mitigate it. The aim of the study is to investigate the effect of three low-calorie diets with different macronutrients composition and distribution along day on glucose metabolism and other health outcomes in overweight or obese shift workers with prediabetes or T2DM.

Methods: In this randomized controlled trial, 120 shift workers with a BMI > 27.5 kg/m2 and diagnosed with prediabetes or T2DM will be recruited. The trial assesses three low-calorie diets effects on glucose metabolism, body composition, and health outcomes over 12 weeks. These diets include: A) high-protein dinner (60% of total daily protein), B) low-protein dinner (15% of total daily protein), and C) normoproteic diet.

Eligibility Criteria

Inclusion

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 glycatedhemoglobin between 5.7 and 6.4%) or type 2 diabetes mellitus (fasting glucose ≥ 126mg/dL and/or glycated hemoglobin ≥ 6.5% and/or currently taking metformin), based onthe criteria of the American Diabetes Association.

  • Engaged in shift work, including night shifts, for at least 1 year and intending tomaintain this schedule in the upcoming months.

  • Provide written informed consent for voluntary participation in the study afterreviewing the participant information sheet and addressing any resulting queries.

Exclusion

Exclusion Criteria:

  • Treatment with antidiabetic medications (oral or subcutaneous) or insulin in thelast 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 monthsprior 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 unstablemanner for at least 6 months prior to study entry.

  • Presence of other chronic conditions that are not well-controlled and couldinterfere with study outcomes, such as cardiovascular disease, renal disease, orliver disease.

  • Presence of uncontrolled endocrine disorders, including hypothyroidism.

  • Use of medications that could interfere with lipid and/or glucose metabolism, unlesstaken stably throughout the study.

  • Consumption of sleep supplements, except for stable use for 6 months with theintention 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 tostudy 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, inthe investigators' judgment, limits uniform dietary intake throughout the study.

  • Any other circumstance that, in the investigators' judgment, would impede adequateadherence to the proposed nutritional intervention (e.g., frequent travel during thestudy, inability to attend visits due to personal or work-related circumstances,etc.).

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Diet
Phase:
Study Start date:
September 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza

    Zaragoza, 50009
    Spain

    Active - Recruiting

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