The Effect of Psychobiotic Use on Mental Health, Quality of Life, Anthropometric and Biochemical Outcomes in Obese Women on a Weight-loss Diet
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
- Changes in Body Weight (kg) from Baseline to Week 4
研究概览
简要总结
The aim of this study was to evaluate the effect of psychobiotic supplementation containing Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071 and Bifidobacterium longum R0175 strains on mental health, quality of life, anthropometric measurements and some biochemical parameters in obese women. In the randomized double-blind placebo-controlled study, 28 obese female participants (14 psychobiotic, 14 placebo) will be given psychobiotic supplement/placebo together with a weight loss diet once a day every day for 4 weeks. Before and after the intervention, anthropometric measurements, blood samples and 24-hour retrospective 3-day food consumption records of the participants will be taken. In addition, the Depression Anxiety Stress Scale (DASS-21) will be administered to measure mental health, the SF-36 Quality of Life Scale to determine quality of life, and the International Physical Activity Questionnaire (IPAQ) to determine physical activity levels. Psychobiotics, which have entered our lives in recent years, have many beneficial effects on mental health through gut microbiota. However, while the effects of psychobiotics on mental health have been studied, their effects on obesity have not been investigated much. This study is unique in that it is the first study to investigate the effect of psychobiotic use on mental health in obese individuals. However, obesity is known to be an inflammatory disease and there is no study in the literature that includes the systemic immune inflammation index (SII) as a biomarker. SII is effective in evaluating the inflammatory and immune response in the body and determining prognosis; it adds value to clinical practice with early diagnosis of diseases, treatment follow-up and a wide range of uses.
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
- Double (Participant, Investigator)
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
- •Healthy adults aged ≥ 18-65 years
- •BMI ≥30 kg/m2
- •Willingness to volunteer
- •Able to give written consent
排除标准
- •Co-administration of probiotics. However, subjects will be eligible to participate after a four (4) week washout period.
- •Pregnant or planning to become pregnant within the next two (2) months.
- •Positive pregnancy test in women of childbearing potential.
- •Use of antibiotic medication (e.g. neomycin, rifaximin) within the last 1 month. If this is the case, the participant will be eligible to participate four (4) weeks after completion of antibiotic treatment (washout period).
- •Individuals with physician-diagnosed psychiatric and neurological conditions.
- •Individuals with irritable bowel syndrome or gastrointestinal disorders.
- •People with immune disorders or possible immunodeficiency states (e.g. due to surgery).
- •Use of anti-inflammatory drugs
- •Use of corticosteroids
- •People who are allergic to milk, corn starch or soya.
- •Foreign nationality.
研究组 & 干预措施
Psychobiotic Group
Participants will receive a psychobiotic supplement along with a weight-loss diet.
干预措施: Psychobiotic Supplement (Dietary Supplement)
Placebo Group
Participants will receive a placebo supplement along with a weight-loss diet.
干预措施: Placebo Supplement (Dietary Supplement)
结局指标
主要结局
Changes in Body Weight (kg) from Baseline to Week 4
时间窗: Baseline and Week 4
Changes in Body Mass Index (BMI) from Baseline to Week 4
时间窗: Baseline and Week 4
Body Mass Index (BMI) will be calculated as weight (kg) / height (m²). Higher BMI values indicate higher body fatness.
次要结局
- Changes in mental health status with DASS-21 from Baseline to Week 4(Baseline and Week 4)
- Changes in Quality of Life with SF-36 from Baseline to Week 4(Baseline and Week 4)
- Changes in C-Reactive Protein (CRP) Levels from Baseline to Week 4(Baseline and Week 4)
- Changes in Interleukin-6 (IL-6) Levels from Baseline to Week 4(Baseline and Week 4)
- Changes in Systemic Immune-Inflammation Index (SII) from Baseline to Week 4(Baseline and Week 4)
研究者
Rabia Melda Karaağaç
Principal Investigator
Medipol University