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OverweightPROTIMENCT06382480

PROTeIn-rich Meals to Control Glucose

A study testing Diet with specific macronutrient composition. in people with Overweight and Obesity, run by German Institute of Human Nutrition at 1 site in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Overweight, Obesity, Prediabetes
What is being tested?
Diet with specific macronutrient composition.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGermany
Study dates
12 Apr 2024to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prediabetes (fasting blood sugar 100-125 mg/dl)
  • Diabetes type 2 (fasting blood sugar \>126 mg/dl)
  • Overweight and obesity (BMI 25-50 kg/m2)

Who cannot join

  • Other diabetes types
  • Insulin treatment
  • Shift work
  • Weight changes \>5% within past 3 months
  • Systemic glucocorticoid therapy
  • Systemic infections
Show all 19Show fewer
  • Severe anemia
  • High blood pressure (\>180/110 mmHg)
  • Endocrinologic, liver and heart disorders
  • Immune diseases
  • Thyroid dysfunction
  • Heart attack or stroke
  • Cancer in the last 2 years
  • Eating disorders, food intolerance/allergy, addiction disorders, digestive disorders intestinal, liver, cardiovascular diseases
  • Hereditary or acquired coagulation disorders
  • Non-interruptible intake of blood thinners (anticoagulants)
  • Specific diets, intermittent fasting
  • Pregnancy or breastfeeding
  • Severe internal or psychiatric disorders or other conditions and drugs therapy that might influence the outcome of the study

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Olga Ramich

    Potsdam, Potsdam-Rehbrücke, 14558

Other trials in Germany

About this study

Official title: Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes

The overall aim is to identify the dietary pattern for prevention and treatment of type 2 diabetes. The specific aim of this pilot project is to compare effects of two diets with different diurnal distribution of carbohydrates and protein on the glucose metabolism in subjects with prediabetes and type 2 diabetes and its effects on inflammatory status.

Read the detailed description

Overweight individual with prediabetes and non-insulin treated type 2 diabetes will be recruited for the study. The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake - a high-protein (HP) breakfast and a high-carb (HC) dinner (HP/HC intervention) vs. a HC breakfast and a HP dinner (HC/HP intervention) - divided by a 4-week wash-out phase. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10E%protein, 60%E carbs, and 30%E fat.

Being tested
Diet with specific macronutrient composition.
Keywords
Glucose, Overweight, Obesity, Prediabetes, Type 2 Diabetes, Metabolism, Chrononutrition, Macronutrient composition, High-protein, High-carb, Isocaloric diet, Prevention and treatment of type 2 diabetes
Medical subject headings
Overweight, Obesity, Prediabetic State, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet with specific macronutrient composition.Other

    The intervention is about an isocaloric diet that differs in terms of distribution of carbohydrates and protein throughout the day. The interventions include a HP-breakfast and a HC-dinner vs. a HC-breakfast and a HP-dinner. A HP low-carb meal (breakfast or dinner) will contain 35%E protein, 35%E carbs, and 30%E fat, and a HC meal (breakfast or dinner) will contain 10%E protein, 60%E carbs, and 30%E fat.

Study groups in NCT06382480
Study groupRoleWhat they receive
HP/HC - HC/HPExperimentalIsocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention.
Receives: Other: Diet with specific macronutrient composition.
HC/HP - HP/HCExperimentalIsocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention.
Receives: Other: Diet with specific macronutrient composition.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean 24-hour glucose

    Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)

    Measured: 4 weeks

Secondary outcomes (19)

  1. Measurement of height

    Height measured by stadiometer

    Measured: 4 weeks

  2. Measurement of body weight

    Body weight measured by body scale

    Measured: 4 weeks

  3. Waist and hip circumference / waist to hip ratio

    Waist and hip circumference measured by tape measure

    Measured: 4 weeks

  4. Systolic and diastolic blood pressure

    Systolic and diastolic blood pressure changes measurement by manometer

    Measured: 4 weeks

  5. Body fat and lean mass

    Body fat and lean mass assessed by bioelectrical impendance analysis (BIA)

    Measured: 4 weeks

  6. Energy expenditure and substrate oxidation rates

    Energy expenditure and substrate oxidation rates assessed by indirect calorimetry

    Measured: 4 weeks

  7. Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))

    GGT, AST, ALT etermined in fasting blood samples

    Measured: 4 weeks

  8. Renal values (creatinine, urea, uric acid)

    Renal values determined in fasting blood samples

    Measured: 4 weeks

  9. Intra- und inter-day glycemic variability

    Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM)

    Measured: 4 weeks

  10. Glucose levels in meal tolerance test (MTT)

    Glucose levels in blood samples collected in MTT

    Measured: 4 weeks

  11. Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)

    Blood levels of metabolic hormones assessed in fasting state and during the MTT

    Measured: 4 weeks

  12. Inflammatory markers and T cell populations analyses

    Level of the inflammatory markers IL-6, TNFa, MCP-1 and T cell populations in circulation and adipose tissue are assessed through blood analysis and fat biopsy

    Measured: 4 weeks

  13. Satiety and hunger scores

    Satiety and hunger scores assessed using Visual Analog Scale (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)

    Measured: 4 weeks

  14. Sleep/wake timing and sleep quality

    Sleep/wake timing and sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and also monitored by an ActiGraph device

    Measured: 4 weeks

  15. Physical activity

    24-h physical activity will be monitored by an ActiGraph device

    Measured: 4 weeks

  16. Adipose tissue transcriptome

    RNA-Seq analysis of subcutaneous adipose tissue sample

    Measured: 4 weeks

  17. Gene expression in peripheral blood mononuclear cells (PBMC)

    Expression of metabolic genes assessed by qPCR

    Measured: 4 weeks

  18. Gut microbiota and microbiome-derived metabolites

    Determined in stool samples and blood plasma

    Measured: 4 weeks

  19. Determination of decision behavior

    Impulsiveness assessed by decision making tasks on computer

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study start12 Apr 2024
  3. Primary completion21 Apr 2026
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Crossover
Model description
The trial will have a cross-over design and compare metabolic effects of two isocaloric 4-week interventions with opposite timely distribution of macronutrient intake divided by a 4-week wash-out phase.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06382480
Sponsor's protocol ID
90/2023
Acronym
PROTIME
Status last verified
Sep 2026
First submitted
15 Mar 2024
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Diet with specific macronutrient composition. in people with Overweight and Obesity, run by German Institute of Human Nutrition at 1 site in Germany.

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 3 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 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 Germany. 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?

This study is still under way. Results are not available in the source record yet.

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?

Mean 24-hour glucose (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06382480.

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 29 Sep 2026.

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