EFFECTS OF DAILY KEFIR CONSUMPTION DURING MEDICAL NUTRITION THERAPY ON BODY COMPOSITION AND PSYCHOLOGICAL WELL-BEING IN WOMEN WITH OBESITY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in body weight (kg) from baseline to week 12
研究概览
简要总结
This randomized controlled study evaluated the effects of daily kefir consumption as an adjunct to medical nutrition therapy on body composition, biochemical parameters, gastrointestinal symptoms, bowel habits, and psychological well-being in women with obesity. Participants were randomly assigned to receive either 200 mL of plain kefir daily together with individualized medical nutrition therapy or individualized medical nutrition therapy alone for 12 weeks. Assessments were performed at baseline, week 6, and week 12. The primary outcome was change in body weight. Secondary outcomes included changes in body composition, biochemical parameters, gastrointestinal symptoms, bowel habits, and psychological well-being.
详细描述
This study was designed as a randomized, parallel-group, controlled clinical trial to evaluate the effects of daily kefir consumption as an adjunct to individualized medical nutrition therapy in women with obesity. Participants were randomly assigned to one of two intervention groups: (1) individualized medical nutrition therapy plus 200 mL of plain kefir consumed daily, or (2) individualized medical nutrition therapy alone. Both interventions were continued for 12 weeks.
Participants were assessed at baseline, week 6, and week 12. The primary outcome was change in body weight. Secondary outcomes included changes in body mass index, body fat mass, muscle mass, biochemical parameters (fasting blood glucose, lipid profile, liver function tests, and related metabolic markers), gastrointestinal symptoms, bowel habits, stool characteristics, and psychological well-being.
The study aimed to investigate whether the addition of daily kefir consumption to individualized medical nutrition therapy could provide additional benefits beyond diet therapy alone for improving obesity-related health outcomes in women.
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
- Single (Care Provider)
盲法说明
This was an open-label study because participants and investigators were aware of the assigned intervention. No masking was implemented.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 years or older. Diagnosis of obesity (BMI ≥30 kg/m²). Willingness to participate in the study and comply with the intervention protocol.
- •Provision of written informed consent.
排除标准
- •Pregnancy or lactation. Current use of antibiotics, probiotic or prebiotic supplements during the study period or within the specified washout period (if applicable in your protocol).
- •Presence of severe gastrointestinal, renal, hepatic, endocrine, or other serious chronic diseases that could affect study outcomes.
- •Known allergy or intolerance to kefir or dairy products. Inability to comply with the intervention or follow-up procedures.
研究组 & 干预措施
Medical Nutrition Therapy + Kefir
Participants received individualized medical nutrition therapy together with 200 mL/day of plain kefir for 12 weeks.
干预措施: Plain Kefir (Dietary Supplement)
Medical Nutrition Therapy + Kefir
Participants received individualized medical nutrition therapy together with 200 mL/day of plain kefir for 12 weeks.
干预措施: Individualized Medical Nutrition Therapy (Behavioral)
Medical Nutrition Therapy
Participants received individualized medical nutrition therapy alone for 12 weeks.
干预措施: Individualized Medical Nutrition Therapy (Behavioral)
结局指标
主要结局
Change in body weight (kg) from baseline to week 12
时间窗: Baseline and week 12
Body weight was measured in kilograms using a calibrated digital scale. The primary outcome was the change in body weight from baseline to week 12.
次要结局
- Change in body fat percentage(Baseline and week 12)
- Change in body mass index (kg/m²)(Baseline and week 12)
- Change in fat mass (kg)(Baseline and week 12)
- Change in muscle mass (kg)(Baseline and week 12)
- Change in visceral fat level(Baseline and week 12)
- Change in fasting blood glucose (mg/dL)(Baseline and week 12)
- Change in fasting insulin (µIU/mL)(Baseline and week 12)
- Change in Psychological Well-Being Scale total score(Baseline and week 12)
- Change in total cholesterol (mg/dL)(Baseline and week 12)
- Change in LDL cholesterol (mg/dL)(Baseline and week 12)
- Change in triglycerides (mg/dL)(Baseline and week 12)
- Change in gastrointestinal symptoms (GSRS total score)(Baseline and week 12)
- Change in Bristol Stool Scale score(Baseline and week 12)
研究者
Pınar Göbel
Assoc Prof Dr
Saglik Bilimleri Universitesi