protocolSection identificationModule nctId: NCT06382480, orgStudyIdInfo id: 90/2023, briefTitle: PROTeIn-rich Meals to Control Glucose, acronym: PROTIME, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: German Institute of Human Nutrition, class: OTHER, collaborators name: Charite University, Berlin, Germany, collaborators name: Helmholtz Center Munich, collaborators name: Hasso Plattner Institute, Potsdam, Germany, descriptionModule briefSummary: 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., conditionsModule conditions: Overweight, conditions: Obesity, conditions: Prediabetes, conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 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., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Diet with specific macronutrient composition., outcomesModule primaryOutcomes measure: Mean 24-hour glucose, secondaryOutcomes measure: Measurement of height, secondaryOutcomes measure: Measurement of body weight, secondaryOutcomes measure: Waist and hip circumference / waist to hip ratio, secondaryOutcomes measure: Systolic and diastolic blood pressure, secondaryOutcomes measure: Body fat and lean mass, secondaryOutcomes measure: Energy expenditure and substrate oxidation rates, secondaryOutcomes measure: Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT)), secondaryOutcomes measure: Renal values (creatinine, urea, uric acid), secondaryOutcomes measure: Intra- und inter-day glycemic variability, secondaryOutcomes measure: Glucose levels in meal tolerance test (MTT), secondaryOutcomes measure: Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin), secondaryOutcomes measure: Inflammatory markers and T cell populations analyses, secondaryOutcomes measure: Satiety and hunger scores, secondaryOutcomes measure: Sleep/wake timing and sleep quality, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Adipose tissue transcriptome, secondaryOutcomes measure: Gene expression in peripheral blood mononuclear cells (PBMC), secondaryOutcomes measure: Gut microbiota and microbiome-derived metabolites, secondaryOutcomes measure: Determination of decision behavior, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Olga Ramich, status: RECRUITING, city: Potsdam, state: Potsdam-Rehbrücke, zip: 14558, country: Germany, contacts name: Olga Ramich, PD Dr., role: CONTACT, phone: +4933200882749, email: olga.ramich@dife.de, contacts name: Marina D'Urso, role: CONTACT, phone: +4933200882690, email: marina.durso@dife.de, geoPoint lat: 52.39886, lon: 13.06566, hasResults: False