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PROTEIN-rike måltider for å kontrollere glukose (PROTIME)

26. september 2026 oppdatert av: Olga Ramich (formerly Pivovarova), German Institute of Human Nutrition

Måltidsbaserte strategier for å forbedre glukosemetabolismen ved prediabetes og 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.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyskland
    • Potsdam-Rehbrücke
      • Potsdam, Potsdam-Rehbrücke, Tyskland, 14558
        • Olga Ramich

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Other diabetes types
  • Insulin treatment
  • Shift work
  • Weight changes >5% within past 3 months
  • Systemic glucocorticoid therapy
  • Systemic infections
  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: HP/HC - HC/HP

Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention.
Annen: Diet with specific macronutrient composition.

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.
Eksperimentell: HC/HP - HP/HC

Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention.
Annen: Diet with specific macronutrient composition.

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mean 24-hour glucose
Tidsramme: 4 weeks

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Measurement of height
Tidsramme: 4 weeks

Height measured by stadiometer
4 weeks
Measurement of body weight
Tidsramme: 4 weeks

Body weight measured by body scale
4 weeks
Waist and hip circumference / waist to hip ratio
Tidsramme: 4 weeks

Waist and hip circumference measured by tape measure
4 weeks
Systolic and diastolic blood pressure
Tidsramme: 4 weeks

Systolic and diastolic blood pressure changes measurement by manometer
4 weeks
Body fat and lean mass
Tidsramme: 4 weeks

Body fat and lean mass assessed by bioelectrical impendance analysis (BIA)
4 weeks
Energy expenditure and substrate oxidation rates
Tidsramme: 4 weeks

Energy expenditure and substrate oxidation rates assessed by indirect calorimetry
4 weeks
Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))
Tidsramme: 4 weeks

GGT, AST, ALT etermined in fasting blood samples
4 weeks
Renal values (creatinine, urea, uric acid)
Tidsramme: 4 weeks

Renal values determined in fasting blood samples
4 weeks
Intra- und inter-day glycemic variability
Tidsramme: 4 weeks

Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM)
4 weeks
Glucose levels in meal tolerance test (MTT)
Tidsramme: 4 weeks

Glucose levels in blood samples collected in MTT
4 weeks
Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)
Tidsramme: 4 weeks

Blood levels of metabolic hormones assessed in fasting state and during the MTT
4 weeks
Inflammatory markers and T cell populations analyses
Tidsramme: 4 weeks

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
4 weeks
Satiety and hunger scores
Tidsramme: 4 weeks

Satiety and hunger scores assessed using Visual Analog Scale (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger)
4 weeks
Sleep/wake timing and sleep quality
Tidsramme: 4 weeks

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
4 weeks
Physical activity
Tidsramme: 4 weeks

24-h physical activity will be monitored by an ActiGraph device
4 weeks
Adipose tissue transcriptome
Tidsramme: 4 weeks

RNA-Seq analysis of subcutaneous adipose tissue sample
4 weeks
Gene expression in peripheral blood mononuclear cells (PBMC)
Tidsramme: 4 weeks

Expression of metabolic genes assessed by qPCR
4 weeks
Gut microbiota and microbiome-derived metabolites
Tidsramme: 4 weeks

Determined in stool samples and blood plasma
4 weeks
Determination of decision behavior
Tidsramme: 4 weeks

Impulsiveness assessed by decision making tasks on computer
4 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

German Institute of Human Nutrition

Samarbeidspartnere

Charite University, Berlin, Germany
Helmholtz Zentrum München
Hasso Plattner Institute, Potsdam, Germany

Etterforskere

  • Hovedetterforsker: Olga Ramich, PD Dr., German Institute of Human Nutrition

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. april 2024

Primær fullføring (Faktiske)

21. april 2026

Studiet fullført (Antatt)

28. februar 2027

Datoer for studieregistrering

Først innsendt

15. mars 2024

Først innsendt som oppfylte QC-kriteriene

21. april 2024

Først lagt ut (Faktiske)

24. april 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 90/2023

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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