ObesityBOR-SAFFNCT07156097
Effects of Boron and Mediterranean Diets on Gut Microbiota and Metabolic Health
A study testing Mediterranean-style Diet (SAFF) and Boron-rich Diet in people with Obesity and Dietary Intervention, run by Dicle University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dietary Intervention, Gut Microbiota
- What is being tested?
- Mediterranean-style Diet (SAFF) and Boron-rich Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2023to 15 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Feray Çağıran Yılmaz
Diyarbakır, Diyarbakır, 21280
About this study
Official title: 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
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.
Read the 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
- Being tested
- Mediterranean-style Diet (SAFF), Boron-rich Diet
- Keywords
- Boron-enriched diet, Mediterranean diet, gut microbiota, obesity, cardiometabolic health, Appetite hormones
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Boron-rich DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Mediterranean-style Diet (SAFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 4 weeks
Secondary outcomes (2)
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.
Measured: Baseline to 4 weeks
Change in Low-Density Lipoprotein Cholesterol
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.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start5 Jan 2023
- Primary completion2 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feray ÇAĞIRAN YILMAZ, Dicle University
- Investigators
- Feray Çağıran Yılmaz, Associate Professor, Principal, Principal investigator, Dicle Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156097
- Sponsor's protocol ID
- 2023/01-19
- Acronym
- BOR-SAFF
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07156097
- Acronym / sponsor ID
- BOR-SAFF / 2023/01-19
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Boron-rich Diet | Experimental | Other: Boron-rich DietParticipants 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 | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Mediterranean-style Diet (SAFF) |
| Boron-rich DietParticipants 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. | Other | Boron-rich Diet |
Primary outcome
Change in Body Mass Index
Time frame: Baseline to 4 weeks
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.
Change in Gut Microbiota Diversity
Time frame: Baseline to 4 weeks
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.
2 secondary outcomes
Change in Serum Leptin Level
Time frame: Baseline to 4 weeks
Change in Low-Density Lipoprotein Cholesterol
Time frame: Baseline to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Feray Çağıran Yılmaz, Associate Professor, Principal principal investigator
Dicle Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean-style Diet (SAFF) and Boron-rich Diet in people with Obesity and Dietary Intervention, run by Dicle University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (time frame: Baseline to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.