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.

NCT06912555 | Recruiting

• 1 other identifier: PI23/558
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Overweight or Obesity; PreDiabetes

Keywords

shift work; hight protein diet

Outcome Measures

Primary Outcomes (7)

• Glucose change.

  Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 months visit with respect to baseline.

  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.

  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.

  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.

  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.

  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.

  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.

  After 3 months of intervention.

Secondary Outcomes (4)

• Total cholesterol change.

  After 3 months of intervention.

• LDL cholesterol change.

  After 3 months of intervention.

• HDL cholesterol change.

  After 3 months of intervention.

• Triglycerides change.

  After 3 months of intervention.

Study Arms (3)

A. Low-calorie and high-protein diet with high-protein dinner (60% of total daily protein)

EXPERIMENTAL

The macronutrient distribution will be initially based on a protein intake of 1.3-1.5 g/kg of body weight. From this protein intake, the total calorie intake will be calculated, and 30% of these calories will be allocated to fat consumption. The remaining calories will be allocated to carbohydrate consumption, depending on the amount of protein consumed. The protein will be distributed as follows: breakfast and lunch (\~40%), and dinner (\~60%). The caloric restriction will be moderate, involving a reduction of 30% of the total energy expenditure, specifically calculated for each individual. This reduction will result in approximately 400-600 kcal decrease per day compared to the participant's usual energy needs. It is important to note that the caloric content of the diet will never be less than 1200 kcal per day, as such a diet may not meet the participant's nutritional requirements.

Other: Diet

B. Low-calorie and high-protein diet with low-protein dinner (15% of total daily protein)

EXPERIMENTAL

The macronutrient distribution will be initially based on a protein intake of 1.3-1.5 g/kg of body weight. From this protein intake, the total calorie intake will be calculated, and 30% of these calories will be allocated to fat consumption. The remaining calories will be allocated to carbohydrate consumption, depending on the amount of protein consumed.The protein will be distributed as follows: breakfast and lunch (\~85%), and dinner (\~15%). The caloric restriction will be moderate, involving a reduction of 30% of the total energy expenditure, specifically calculated for each individual. This reduction will result in approximately 400-600 kcal decrease per day compared to the participant's usual energy needs. It is important to note that the caloric content of the diet will never be less than 1200 kcal per day, as such a diet may not meet the participant's nutritional requirements.

Other: Diet

C. Low-calorie and regular-protein diet

EXPERIMENTAL

The macronutrient distribution will be initially based on a protein intake of 0.8 g/kg of body weight. From this protein intake, the total calorie intake will be calculated, and 30% of these calories will be allocated to fat consumption. The remaining calories will be allocated to carbohydrate consumption, depending on the amount of protein consumed. The caloric restriction will be moderate, involving a reduction of 30% of the total energy expenditure, specifically calculated for each individual. This reduction will result in approximately 400-600 kcal decrease per day compared to the participant's usual energy needs. It is important to note that the caloric content of the diet will never be less than 1200 kcal per day, as such a diet may not meet the participant's nutritional requirements.

Other: Diet

Interventions

Diet OTHER

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.

A. Low-calorie and high-protein diet with high-protein dinner (60% of total daily protein)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• Hospital Miguel Servet: collaborator

Study Sites (1)

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

Zaragoza, Spain, 50009, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Prediabetic State

Interventions

Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Rocío Mateo-Gallego, PhD

CONTACT

+34 976 71 6818; rmateo@unizar.es

Itziar Lamiquiz-Moneo, PhD

CONTACT

itziarlamiquiz@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 4, 2025
• Study Start: September 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)