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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boron-rich Diet | Experimental | Participants followed a 4-week dietary intervention emphasizing boron-rich foods (e.g., legumes, nuts, dried fruits). The aim was to assess effects on obesity, microbiota composition, appetite hormones, and cardiometabolic risk markers. |
|
| Mediterranean-style Diet (SAFF) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean-style Diet (SAFF) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index | BMI will be calculated as weight (kg) divided by height (m²). Weight will be measured using a calibrated digital scale and height with a stadiometer by trained staff following standardized procedures. The between-group difference in BMI change will be assessed to evaluate the effect of the interventions on obesity outcomes. | Baseline to 4 weeks |
| Change in Gut Microbiota Diversity | Stool samples will be collected at baseline and 4 weeks. 16S rRNA gene sequencing will be performed; alpha diversity will be calculated using the Shannon Index. Higher values indicate greater within-sample diversity. | Baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Leptin Level | Fasting venous blood will be collected in the morning. Serum leptin will be quantified using a validated ELISA kit according to the manufacturer's instructions. Changes will be analyzed within and between diet arms. | Baseline to 4 weeks |
| Change in Low-Density Lipoprotein Cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
The study population is restricted to female participants. Only women who meet the inclusion criteria will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Feray Çağıran Yılmaz, Associate Professor, Principal | Dicle Üniversitesi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feray Çağıran Yılmaz | Diyarbakır | Diyarbakır | 21280 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Participants were randomly assigned to one of two parallel groups: a boron-rich diet group or a Mediterranean-style diet group. Each intervention was applied for 4 weeks, and outcomes related to obesity, microbiota, cardiometabolic risk markers, and appetite-regulating hormones were assessed
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No masking was applied. Both participants and investigators were aware of the dietary intervention assignment
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| Boron-rich Diet | Other | 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. |
|
Fasting lipid profile will be measured using an automated analyzer in the central laboratory. LDL-C will be calculated directly or via the Friedewald equation when applicable. The outcome represents the change in LDL-C from baseline to end of intervention. |
| Baseline to 4 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |