Clinical trial NCT06382480: PROTeIn-rich Meals to Control Glucose
Official title: Meal Timing-based Strategies to Improve Glucose Metabolism in Prediabetes and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight
Obesity
Prediabetes
Type 2 Diabetes
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
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Helmholtz Center Munich
name: Hasso Plattner Institute, Potsdam, Germany
First posted: 2024-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Other diabetes types
* Insulin treatment
* Shift work
* Weight changes \&gt;5% within past 3 months
* Systemic glucocorticoid therapy
* Systemic infections
* Severe anemia
* High blood pressure (\&gt;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

Primary outcomes:
measure: Mean 24-hour glucose
timeFrame: 4 weeks
Secondary outcomes:
measure: Measurement of height
timeFrame: 4 weeks
measure: Measurement of body weight
timeFrame: 4 weeks
measure: Waist and hip circumference / waist to hip ratio
timeFrame: 4 weeks
measure: Systolic and diastolic blood pressure
timeFrame: 4 weeks
measure: Body fat and lean mass
timeFrame: 4 weeks
measure: Energy expenditure and substrate oxidation rates
timeFrame: 4 weeks
measure: Hepatic values (gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT))
timeFrame: 4 weeks
measure: Renal values (creatinine, urea, uric acid)
timeFrame: 4 weeks
measure: Intra- und inter-day glycemic variability
timeFrame: 4 weeks
measure: Glucose levels in meal tolerance test (MTT)
timeFrame: 4 weeks
measure: Metabolic hormones (insulin, C-peptide, glucagon, glucagon-like peptite 1(GLP-1), gastric inhibitory polypeptide (GIP), peptide YY (PYY), ghrelin, adiponectin, leptin)
timeFrame: 4 weeks
measure: Inflammatory markers and T cell populations analyses
timeFrame: 4 weeks
measure: Satiety and hunger scores
timeFrame: 4 weeks
measure: Sleep/wake timing and sleep quality
timeFrame: 4 weeks
measure: Physical activity
timeFrame: 4 weeks
measure: Adipose tissue transcriptome
timeFrame: 4 weeks
measure: Gene expression in peripheral blood mononuclear cells (PBMC)
timeFrame: 4 weeks
measure: Gut microbiota and microbiome-derived metabolites
timeFrame: 4 weeks
measure: Determination of decision behavior
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: Olga Ramich
state: Potsdam-Rehbrücke
Study officials:
affiliation: German Institute of Human Nutrition
name: Olga Ramich, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: