Type 2 DiabetesNCT06912555
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.
A study testing Diet in people with Type 2 Diabetes and Overweight or Obesity, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Overweight or Obesity, PreDiabetes
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza
Zaragoza, Spain, 50009
About this study
Official title: 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.
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
- Being tested
- Diet
- Keywords
- shift work, hight protein diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
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.
DietOther
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.
DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose change.
Glucose change assessed by difference in fasting glucose concentration (mg/dL and %) comparing 3 months visit with respect to baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 3 months of intervention.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 3 months of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Sep 2024
- Primary completion31 Aug 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Miguel Servet
- Responsible party
- Principal investigator, Rocio Mateo-Gallego, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912555
- Sponsor's protocol ID
- PI23/558
- Status last verified
- May 2026
- First submitted
- 24 Mar 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06912555
- Acronym / sponsor ID
- PI23/558
- Conditions
- Type 2 Diabetes, Overweight or Obesity, PreDiabetes
- Keywords
- shift work, hight protein diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- Hospital Miguel Servet
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A. Low-calorie and high-protein diet with high-protein dinner (60% of total daily protein) | Experimental | Other: DietThe 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. |
| B. Low-calorie and high-protein diet with low-protein dinner (15% of total daily protein) | Experimental | Other: DietThe 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. |
| C. Low-calorie and regular-protein diet | Experimental | Other: DietThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietThe 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 | A. Low-calorie and high-protein diet with high-protein dinner (60% of total daily protein) |
| DietThe 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 | B. Low-calorie and high-protein diet with low-protein dinner (15% of total daily protein) |
| DietThe 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. | Other | C. Low-calorie and regular-protein diet |
Primary outcome
Glucose change.
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.
Glycated hemoglobin change.
Time frame: After 3 months of intervention.
Glycated change assessed by difference in glycated hemoglobin concentration (%) comparing 3 months visit with respect to baseline.
Insulin change.
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.
HOMA-IR change.
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.
Body fat mass change.
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.
Fat-free mass change.
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.
Visceral fat mass change.
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.
4 secondary outcomes
Total cholesterol change.
Time frame: After 3 months of intervention.
LDL cholesterol change.
Time frame: After 3 months of intervention.
HDL cholesterol change.
Time frame: After 3 months of intervention.
Triglycerides change.
Time frame: After 3 months of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Type 2 Diabetes and Overweight or Obesity, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose change. (time frame: After 3 months of intervention.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.