Single-arm, Pre-Post Clinical Trial on the Effect of Food Formulations Containing Antioxidants, Prebiotic Fibers, and Oat Beta-glucans in Individuals at Risk of Metabolic Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in postprandial glycemia
研究概览
简要总结
The goal of this clinical trial is to evaluate whether introducing specific functional foods into the diet of individuals at risk of developing metabolic syndrome leads to improvements in key metabolic and oxidative health parameters.
The main questions it aims to answer are:
Does the consumption of these functional foods reduce post-prandial glycemia? Does daily intake of these formulations improve other health indicators such as body weight, body composition, lipid profile, and oxidative metabolomic markers?
The functional food formulations used in this study include:
A blend of multifunctional ingredients derived from apple and grape by-products Added prebiotic fibers (inulin) Oat β-glucans Omega-3 fatty acids
Participants will:
Consume the assigned functional food formulations daily Attend regular clinic visits for physiological measurements and blood tests Undergo assessments of body composition, serum lipids, and serum metabolomics
Primary Study Objective:
Variation in post-prandial glycemia
Secondary Objectives:
Reduction in BMI Changes in body composition Changes in serum lipid profile Changes in serum oxidative-related metabolomics
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years
- •Individuals who do not have metabolic syndrome
- •Presence of abdominal circumference >94 cm for men or >80 cm for women, or a body mass index (BMI) between 25 and 34.9 kg/m², and at least two of the following parameters:
- •Impaired glucose tolerance (IGT) (≥100 mg/dL), or borderline hypertension (systolic 120-139 mmHg, diastolic 80-90 mmHg), or mild hypercholesterolemia (200-239 mg/dL)
- •Absence of any long-term pharmacological treatment for diabetes, hypertension, dyslipidemia, hyperuricemia, or other chronic conditions
排除标准
- •Individuals with metabolic syndrome
- •Continuous pharmacological treatments for dysmetabolic conditions
- •BMI <18.5 kg/m² or >35 kg/m²
- •Glycated hemoglobin (HbA1c) > 6%
- •Pregnancy
结局指标
主要结局
Changes in postprandial glycemia
时间窗: PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8
次要结局
- Changes in serum lipid profile(PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8)
- Changes in serum oxidative related metabolomics(PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8)
- Changes in BMI(PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8)
- Changes in body composition(PHASE 1: from baseline to week 8; PHASE 2: from baseline to week 8)