PROTeIn-rich Meals to Control Glucose

Obesity Clinical Trial

— PROTIME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382480
• Other study ID #: 90/2023
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: April 2024
• Source: German Institute of Human Nutrition
• Contact: Olga Ramich, PD Dr.
• Phone: +4933200882749
• Email: olga.ramich[@]dife.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 its effects on inflammatory status.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 28, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Obesity
• Overweight
• Prediabetes
• Prediabetic State
• Type 2 Diabetes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	Olga Ramich	Potsdam	Potsdam-Rehbrücke

Sponsors (4)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	Charite University, Berlin, Germany, Hasso Plattner Institute, Potsdam, Germany, Helmholtz Center Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour glucose	Mean 24-hour glucose assessed by continuous glucose monitoring (CGM)	4 weeks
Secondary	Measurement of height	Height measured by stadiometer	4 weeks
Secondary	Measurement of body weight	Body weight measured by body scale	4 weeks
Secondary	Waist and hip circumference / waist to hip ratio	Waist and hip circumference measured by tape measure	4 weeks
Secondary	Systolic and diastolic blood pressure	Systolic and diastolic blood pressure changes measurement by manometer	4 weeks
Secondary	Body fat and lean mass	Body fat and lean mass assessed by bioelectrical impendance analysis (BIA)	4 weeks
Secondary	Energy expenditure and substrate oxidation rates	Energy expenditure and substrate oxidation rates assessed by indirect calorimetry	4 weeks
Secondary	Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))	GGT, AST, ALT etermined in fasting blood samples	4 weeks
Secondary	Renal values (creatinine, urea, uric acid)	Renal values determined in fasting blood samples	4 weeks
Secondary	Intra- und inter-day glycemic variability	Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM)	4 weeks
Secondary	Glucose levels in meal tolerance test (MTT)	Glucose levels in blood samples collected in MTT	4 weeks
Secondary	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	4 weeks
Secondary	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	4 weeks
Secondary	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)	4 weeks
Secondary	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	4 weeks
Secondary	Physical activity	24-h physical activity will be monitored by an ActiGraph device	4 weeks
Secondary	Adipose tissue transcriptome	RNA-Seq analysis of subcutaneous adipose tissue sample	4 weeks
Secondary	Gene expression in peripheral blood mononuclear cells (PBMC)	Expression of metabolic genes assessed by qPCR	4 weeks
Secondary	Gut microbiota and microbiome-derived metabolites	Determined in stool samples and blood plasma	4 weeks
Secondary	Determination of decision behavior	Impulsiveness assessed by decision making tasks on computer	4 weeks