PROTeIn-rich Meals to Control Glucose

Not Applicable

Recruiting

• Conditions: Obesity; Prediabetes; Type 2 Diabetes; Overweight
• Interventions: Other: Diet with specific macronutrient composition.

• Registration Number: NCT06382480
• Lead Sponsor: German Institute of Human Nutrition

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-03-15
• Status Verified: 2024-04
• Study Start: 2024-04-12
• Study First Submitted QC: 2024-04-21
• Last Update Submitted: 2024-04-21
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24
• Primary Completion: 2026-12-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HP/HC - HC/HP	Diet with specific macronutrient composition.	Isocaloric 4-week HP/HC intervention followed by a 4-week HC/HP intervention.
HC/HP - HP/HC	Diet with specific macronutrient composition.	Isocaloric 4-week HC/HP intervention followed by a 4-week HP/HC intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Waist and hip circumference / waist to hip ratio	4 weeks	Waist and hip circumference measured by tape measure
Systolic and diastolic blood pressure	4 weeks	Systolic and diastolic blood pressure changes measurement by manometer
Renal values (creatinine, urea, uric acid)	4 weeks	Renal values determined in fasting blood samples
Intra- und inter-day glycemic variability	4 weeks	Indices of intra- and inter-day glycemic variability assessed by continuous glucose monitoring (CGM)
Inflammatory markers and T cell populations analyses	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
Energy expenditure and substrate oxidation rates	4 weeks	Energy expenditure and substrate oxidation rates assessed by indirect calorimetry
Measurement of height	4 weeks	Height measured by stadiometer
Body fat and lean mass	4 weeks	Body fat and lean mass assessed by bioelectrical impendance analysis (BIA)
Glucose levels in meal tolerance test (MTT)	4 weeks	Glucose levels in blood samples collected in MTT
Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)	4 weeks	Blood levels of metabolic hormones assessed in fasting state and during the MTT
Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))	4 weeks	GGT, AST, ALT etermined in fasting blood samples
Physical activity	4 weeks	24-h physical activity will be monitored by an ActiGraph device
Adipose tissue transcriptome	4 weeks	RNA-Seq analysis of subcutaneous adipose tissue sample
Gene expression in peripheral blood mononuclear cells (PBMC)	4 weeks	Expression of metabolic genes assessed by qPCR
Satiety and hunger scores	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)
Sleep/wake timing and sleep quality	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
Gut microbiota and microbiome-derived metabolites	4 weeks	Determined in stool samples and blood plasma
Determination of decision behavior	4 weeks	Impulsiveness assessed by decision making tasks on computer
Measurement of body weight	4 weeks	Body weight measured by body scale

Trial Locations

Locations (1)

Olga Ramich; 🇩🇪 Potsdam, Potsdam-Rehbrücke, Germany