NCT07156097

Effects of Boron and Mediterranean Diets on Gut Microbiota and Metabolic Health

Comparative Effects of a Boron-Enriched Diet and a Mediterranean-Style Diet on Gut Microbiota, Appetite-Regulating Hormones, and Cardiometabolic Parameters in Obese Adults: A Controlled Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dicle University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study investigated the effects of a boron-rich diet compared with a Mediterranean-style diet (Smart Alternative Food Formulation; SAFF) on obesity-related outcomes in adults. Forty obese participants were randomly assigned to receive either a boron-rich diet or the SAFF diet for four weeks. Anthropometric measurements, biochemical parameters, and adipokine levels were evaluated before and after the intervention. The primary aim was to determine whether dietary boron intake can improve metabolic health, lipid profile, and obesity-related hormonal regulation compared to a widely accepted dietary model. Findings from this trial may contribute to understanding the potential role of boron and diet-microbiota interactions in obesity management and provide evidence for future nutritional strategies.

Detailed description

This single-center, prospective, randomized controlled clinical trial was conducted to investigate the effects of a boron-rich diet compared to a Mediterranean-style diet (SAFF) on obesity, metabolic parameters, and gut microbiota composition in adults with obesity. The trial was carried out at Dicle University, Diyarbakır, Turkey, over a 4-week intervention period. A total of 40 obese participants (Body Mass Index \[BMI\] ≥30 kg/m²), aged 18-65 years, were enrolled following eligibility screening. Inclusion criteria comprised clinically stable individuals without severe systemic disease, no recent antibiotic or probiotic use within the past month, and willingness to comply with dietary instructions. Exclusion criteria included pregnancy or lactation, use of medications affecting weight or metabolism, history of gastrointestinal surgery, or presence of chronic inflammatory diseases. Participants were randomized into two groups: Boron-Rich Diet Group (n=20): Participants received a structured diet plan enriched with natural boron sources (such as dried fruits, nuts, legumes, and selected vegetables), formulated to provide a daily boron intake aligned with nutritional safety guidelines. SAFF (Mediterranean-Style) Diet Group (n=20): Participants followed a diet rich in olive oil, whole grains, legumes, fruits, vegetables, and moderate fish consumption, consistent with Mediterranean dietary principles. Both groups received equivalent calorie prescriptions tailored to individual energy requirements to promote weight reduction while ensuring comparable macronutrient distribution. Participants received weekly dietary counseling to ensure adherence. Outcome Measures: Primary Outcomes: Changes in anthropometric parameters (body weight, BMI, waist circumference) and biochemical markers (lipid profile, fasting glucose, insulin, Homeostatic Model Assessment for Insulin Resistance \[HOMA-IR\]). Secondary Outcomes: Serum adipokines (leptin, adiponectin), inflammatory biomarkers, and gut microbiota composition assessed through stool sampling and next-generation sequencing. Statistical analysis was performed using appropriate parametric or non-parametric tests depending on distribution. Effect sizes and 95% confidence intervals were reported to evaluate the magnitude of differences. Ethical approval for the study was granted by the Non-Interventional Research Ethics Committee of Firat University (Decision No: 2023/01-19). The trial was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants. This study contributes novel clinical evidence regarding the potential role of boron-enriched diets as a nutritional intervention for obesity management and provides insights into the diet-microbiota-metabolism relationship.

Conditions

• Obesity
• Dietary Intervention
• Gut Microbiota
• Cardiometabolic Risk Factors
• Appetite-Regulating Hormones

Interventions

Type	Name	Description
OTHER	Mediterranean-style Diet (SAFF)	Participants followed a 4-week Mediterranean-style dietary pattern (SAFF), characterized by high intake of vegetables, fruits, whole grains, olive oil, and lean protein sources. This arm served as a comparator for the boron-rich diet.
OTHER	Boron-rich Diet	Participants assigned to this arm will follow a boron-rich dietary pattern for 4 weeks. The diet includes foods naturally high in boron (e.g., dried fruits, nuts, legumes, and boron-rich water). Daily dietary intake will be monitored and adjusted to ensure consistent boron exposure.

Timeline

• Start date: 2023-01-05
• Primary completion: 2023-02-02
• Completion: 2023-03-15
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: Turkey (Türkiye)