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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was applied. Both participants and investigators were aware of the dietary intervention assignment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Body Mass Index
时间窗: 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
时间窗: 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.
次要结局
- Change in Serum Leptin Level(Baseline to 4 weeks)
- Change in Low-Density Lipoprotein Cholesterol(Baseline to 4 weeks)
研究者
Feray ÇAĞIRAN YILMAZ
Associate Professor
Dicle University