Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Zaragoza, Spain, 50009
NCT Number: NCT06912555
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Zaragoza, Spain, 50009
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The nutritional plan will be initially based on a protein intake of 1.3 to 1.5 g per kilogram of body weight. From this, the total daily calorie intake is calculated, with 30% of the calories allocated to fats. The remaining calories will be assigned to carbohydrates, depending on the protein intake. Protein distribution will be approximately 40% at breakfast and lunch, and 60% at dinner. Caloric restriction will be moderate, reducing the total energy expenditure by 30%-calculated individually-which translates to an approximate decrease of 400 to 600 kcal per day compared to the participant's usual energy needs. It is important to note that the diet will never provide less than 1200 kcal per day to ensure that the minimum nutritional requirements are met.
Time frame: After 3 months of intervention.
Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
Glycated change assessed by difference in glycated hemoglobin concentration (%) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
Insulin change assessed by difference in fasting insulin concentration (UI/mL and %) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
HOMA-IR change assessed by difference in HOMA-IR concentration (absolute units and %) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
Body fat mass change assessed by difference in fat mass (%) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
Fat-free mass change assessed by difference in fat free-mass (%) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
Visceral fat mass change assessed by difference in visceral fat mass (kg and %) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
Total cholesterol change assessed by difference in fasting total cholesterol concentration (mg/dL and %) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
LDL cholesterol change assessed by difference in fasting LDL cholesterol concentration (mg/dL and %) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
HDL cholesterol change assessed by difference in fasting HDL cholesterol concentration (mg/dL and %) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
Triglycerides change assessed by difference in fasting Triglycerides concentration (mg/dL and %) comparing 3 months visit with respect to baseline.
Universidad de Zaragoza
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05648383
Body Weight, Cardiovascular Diseases
Tirana, Rruga E Dibrës, Albania
View Trial DetailsNCT04634890
Body Weight, Diabetes Mellitus
Bialystok, Podlaskie Voivodeship, Poland
View Trial DetailsNCT05358444
Body Weight, Diabetes Mellitus
Baltimore, Maryland, United States
View Trial DetailsNCT04931836
Behavior, Body Weight
Minneapolis, Minnesota, United States
View Trial Details