Obesity, Diabetes Mellitus Type 2
Conditions
Interventions
This is a two-arm, randomized, double-blind, crossover, and placebo-controlled clinical trial, with a total of 42 participants recruited for the study, comprising 21 in the experimental group (collage
In this experimental design, each of the 42 participants will act as their own control, receiving both interventions, hydrolyzed collagen and placebo, in distinct phases
Participants will be randomized, i.e., randomly allocated using randomization software, into one of two sequences (collagen and erythritol, or erythritol and collagen)
Randomization will be stratified by defined age groups and by sex to ensure an equitable balance of these variables between treatment groups and minimize biases
The study is double-blind, meaning that neither the participants nor the research and data analysis team, with the exception of the professional responsible for coding and distributing the supplements
To maintain blinding, the hydrolyzed collagen and placebo will have similar or identical packaging, color, flavor, and appearance
In the first phase, 21 participants will receive 10 grams of hydrolyzed collagen per day (5 grams before breakfast and 5 grams before lunch) for 8 weeks, and 21 participants will receive 10 grams of p
After the first phase, participants will undergo a washout period lasting 2 weeks
The 2-week washout period will be implemented between the intervention phases to ensure complete elimination of any residual effect from the first intervention before the start of the second
In the second phase, the 21 participants who received collagen i
Sponsors
Universidade Federal de Lavras
Universidade Federal de Lavras
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults over 18 years of age, able to provide free and informed consent; Diagnosis of Obesity or Overweight and Glycemic Dysregulation: Body Mass Index (BMI) between 25 and 39.9 kg/m² and/or waist circumference > 88 cm for women and > 102 cm for men, and/or Waist-to-Hip Ratio (WHR) > 0.5; Pre-diabetes: Fasting glucose between 100-125 mg/dL OR Glycated Hemoglobin (HbA1c) between 5.7-7.0% OR Oral Glucose Tolerance Test (OGTT) with 2-hour post-load glucose between 140-199 mg/dL, without medication use or only on metformin; Type 2 Diabetes Mellitus (T2DM): Individuals using only stable-dose metformin or lifestyle modifications for glycemic control; Stable weight (fluctuation of ± 3 kg) in the last 3 months before screening
Exclusion criteria
Exclusion criteria: Smokers; Type 1 or Type 2 Diabetes Mellitus using insulin, sulfonylureas, Glucagon-like Peptide-1 agonists, or other antidiabetic medications that could mask the effect of the intervention (except metformin, if included in the inclusion criteria); Glycated Hemoglobin > 8.0%, indicating inadequate glycemic control that would require more intensive pharmacological interventions and could mask the effect of the nutritional intervention; Severe clinical conditions such as chronic kidney disease (stage 3 or higher, estimated glomerular filtration rate < 60 mL/min/1.73m²), significant chronic liver disease (Aspartate Aminotransferase or Alanine Aminotransferase > 3x the upper limit of normal), severe cardiovascular disease (myocardial infarction, stroke in the last 6 months, decompensated heart failure, unstable angina), active inflammatory bowel diseases (Crohn's Disease, Ulcerative Colitis), autoimmune diseases, except Hashimoto's, cancer undergoing treatment in the last 5 years; Use of Concomitant Medications: Systemic corticosteroids, medications that significantly affect glucose metabolism or gastrointestinal function (e.g., SGLT2 inhibitors, glitazones, some psychotropics); Collagen supplements, in the 3 months prior to the study; Regular use of laxatives or other supplements (e.g., other high-dose fibers, specific probiotics/prebiotics) that could impact intestinal health or glucose metabolism, and that cannot be discontinued during the study; Antibiotics in the last 3 months before the intervention; Surgical Conditions: History of bariatric surgery or other gastrointestinal surgeries that significantly alter absorption or intestinal transit; Specific Conditions: Pregnancy or breastfeeding, eating disorders (anorexia, bulimia nervosa), alcohol or drug abuse, known allergy or intolerance to any component of the test product or placebo; Inability to Consent: Any physical or mental condition that prevents understanding and providing informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the modulation of postprandial glycemia and insulin sensitivity, with an expected reduction of up to 53% in the Area Under the Curve (AUC) of postprandial glucose, as evidenced in previous studies. Evaluate the acute effect on postprandial glycemia, using the quantification of plasma glucose at specific time points (30, 60, 90, 120 minutes) after a standardized meal in calories and macronutrients, through the postprandial glycemic peak, the Area Under the Curve of postprandial glucose, and the Minimum Clinically Important Difference for the mean difference of the glucose peak and the Area Under the Curve of postprandial glucose. Furthermore, the chronic effect on glycemic response and insulin sensitivity will be evaluated through the modulation of insulin resistance and glycemia from baseline (time zero) to the end of the intervention (8 weeks), between the intervention group (Hydrolyzed Collagen) and the control group (Placebo), using Continuous Glucose Monitoring (CGM) and the calculation of the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). The expected completion date of the study is 2 years from its start | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the difference in the change of biochemical, inflammatory, and metabolic outcomes, reflecting systemic improvement, which encompasses the difference in the change of Homeostatic Model Assessment for Insulin Resistance (fasting glucose and insulin), fasting glucose and continuously monitored glucose, fasting insulin, Glucagon, Pancreatic Polypeptide, Glycated Hemoglobin (percentage), lipid profile (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides), high-sensitivity C-Reactive Protein, Interleukin-6, C-C Chemokine Ligand 2/Monocyte Chemoattractant Protein-1, Interferon-gamma, Tumor Necrosis Factor alpha, C-peptide, uric acid levels, and hepatic enzymes (Alanine Aminotransferase, Aspartate Aminotransferase, Gamma-Glutamyl Transferase); the difference in the change of intestinal permeability levels, such as Interleukin-22, zonulin, and lipopolysaccharides; the gastrointestinal modulation outcomes such as the change in plasma levels of active Glucagon-like Peptide-1, glucose-dependent insulinotropic polypeptide, and active Peptide YY, and the alteration in intestinal microbiota profile (composition and diversity) and short-chain fatty acid production; the difference in the change of subjective satiety, appetite, and eating behavior scores measured by standardized Visual Analogue Scales and 24-hour dietary recalls with dietary inflammatory index analysis; the difference in the change of anthropometric and body composition outcomes, such as body weight (kilograms), Body Mass Index (kilograms per square meter), waist circumference (centimeters), hip circumference (centimeters), and waist-hip ratio, always measured with the same measuring tape, and body fat percentage by Bioelectrical Impedance Analysis; the intervention adherence outcomes, including the proportion of consumed doses and the retention rate; and the safety and tolerability outcomes, such as frequency, type, and severity of reported adverse ev | — |
Countries
Brazil
Contacts
Public ContactAndrezza Santiago
Universidade Federal de Lavras
Outcome results
None listed