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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
120
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.
The macronutrient plan will include a protein intake of 1.3 to 1.5 g per kilogram of body weight. Based on this protein amount, the total daily caloric intake will be determined, allocating 30% of the calories to fat consumption. The remaining calories will be assigned to carbohydrates, proportional to the protein intake. Protein distribution will be approximately 85% during breakfast and lunch and 15% at dinner. The caloric restriction will be moderate, with a 30% reduction in total energy expenditure calculated individually, resulting in 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 contain fewer than 1200 kcal per day, ensuring that the participant's nutritional requirements are met.
The macronutrient plan will include a protein intake of 0.8 g per kilogram of body weight. From this protein amount, the total daily calorie intake will be calculated, with 30% of the calories allocated to fats. The remaining calories will be assigned to carbohydrates, depending on the protein intake. 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 contain fewer than 1200 kcal per day, ensuring that the participant's nutritional requirements are met.
Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Zaragoza, Spain, Spain
RECRUITINGGlucose change.
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 hemoglobin change.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Triglycerides change assessed by difference in fasting Triglycerides concentration (mg/dL and %) comparing 3 months visit with respect to baseline.
Time frame: After 3 months of intervention.
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