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

NCT07156097 | Completed

• 1 other identifier: 2023/01-19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Boron-enriched diet; Mediterranean diet; gut microbiota; obesity; cardiometabolic health; Appetite hormones

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Change in Serum Leptin Level

  Baseline to 4 weeks

• Change in Low-Density Lipoprotein Cholesterol

  Baseline to 4 weeks

Study Arms (2)

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.

Other: Boron-rich Diet

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.

Other: Mediterranean-style Diet (SAFF)

Interventions

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.

Mediterranean-style Diet (SAFF)

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.

Boron-rich Diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: The study population is restricted to female participants. Only women who meet the inclusion criteria will be enrolled.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged 18-65 years
• Body Mass Index (BMI) ≥30 kg/m² (diagnosis of obesity)
• Willingness to participate in the 4-week dietary intervention
• Ability to provide written informed consent

You may not qualify if:

• Presence of chronic diseases (e.g., diabetes, cardiovascular disease, renal disease, gastrointestinal disorders)
• Current use of medications or dietary supplements affecting weight, metabolism, or gut microbiota
• Use of probiotics, prebiotics, or commercial weight loss products in the past 3 months
• Pregnancy or lactation
• Known food allergies or intolerances incompatible with the prescribed diets
• Inability to comply with study procedures or dietary intervention

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Feray Çağıran Yılmaz

Diyarbakır, Diyarbakır, 21280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Feray Çağıran Yılmaz, Associate Professor, Principal

  Dicle Üniversitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking was applied. Both participants and investigators were aware of the dietary intervention assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 4, 2025
• Study Start: January 5, 2023
• Primary Completion: February 2, 2023
• Study Completion: March 15, 2023
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)