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.

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Type 2 DiabetesOverweight or ObesityPreDiabetes
Interventions
OTHER

Diet

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.

OTHER

Diet

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.

OTHER

Diet

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.

Trial Locations (1)

50009

RECRUITING

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

All Listed Sponsors
collaborator

Hospital Miguel Servet

OTHER

lead

Universidad de Zaragoza

OTHER