Impact of Probiotics on Weight Control and Body Composition in Overweight and Obese Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
The aim of the study is to evaluate the potential of probiotics on weight management. It is hypothesized that the consumption of 1 capsule of probiotics daily will modulate the intestinal gut microbiota thereby reducing body weight and fat compared to those who do not consume probiotics. In addition, a diet supplemented with probiotics can be expected to be more beneficial than a diet without probiotic supplementation in impacting biomarkers of obesity-associated disorders including diabetes, hypertension and cardiovascular disease (CVD).
详细描述
Overweight, obese men and women volunteers aged between 18-65 yrs with BMI greater than or equal to 25 will be recruited from the Winnipeg (Manitoba, Canada) area to participate in a two arm crossover, randomized, double-blind, placebo-controlled, free-living intervention study for 60 days per study period following obtainment of informed consent. Participants will be informed to maintain their usual diets as well as their physical activity level.
After obtaining consent, participants will be randomized to receive either 1 capsule containing probiotics, or 1 capsule of placebo daily for 60 days. Compared with the probiotic capsules, the placebo contains the same carrier material and is similar in size, shape and taste.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight, obese men and women volunteers aged between 18-65 yrs
- •BMI equal to or greater than 25
- •Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits.
- •Willingness to discontinue consumption of fermented foods or probiotics (e.g. yoghourts, with live, active cultures or supplements), laxatives, prebiotics and any substances for control body weight.
- •Able to provide informed consent.
- •Women of childbearing potential with a negative pregnancy test at screening.
排除标准
- •BMI greater than 35
- •Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease.
- •Those currently taking (or have taken within the last 3 months) cholesterol-lowering, triglyceride-lowering or hypertension medications.
- •Those currently taking (or have taken within the last 3 months) lipid-lowering supplements, (e.g., omega-3 supplements, plant sterols/stanols foods and/or supplements, fibre, etc).
- •Allergic to milk, soy, or yeast (some of our probiotics strains may contains these items).
- •Use of another investigational product within 3 months of the screening visit.
- •Positive pregnancy test in women of child-bearing potential.
- •Known to be pregnant or breast-feeding or planning on becoming pregnant in the next 18 months.
- •Women of child-bearing potential not using effective contraception.
- •Use of any other treatments (medication or nutritional program) affecting body weight, food intake and/or energy expenditure.
- •Menopausal women.
- •Weight gain or loss of at least 10lbs in previous three months.
- •Uncontrolled angina within the past six months.
- •Cancer treatment (radiation, chemotherapy, surgery) within past six months or any other treatment or condition known to weaken the immune system (such as systemic corticosteroids or HIV/AIDS).
- •Any physical condition deemed likely to significantly interfere with individuals' ability to participate in a nutritional intervention.
- •Currently or at any point during the study participating in Weight Watcher's or another weight loss program or taking a medication for weight loss.
- •History of drug or alcohol (> 2 drinks daily) abuse.
- •Abnormal thyroid hormone levels.
- •Immune-compromised conditions.
- •Participant experiencing nausea, fever, vomiting, bloody diarrhoea or severe abdominal pain (past week and chronic).
- •Participants exercising > 15 miles/wk or 4,000 kcal/wk.
研究组 & 干预措施
Probiotics
1 capsule per day containing probiotics
干预措施: Probiotics (Dietary Supplement)
Placebo
1 capsule per day without probiotics
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Body weight
时间窗: 60 days
次要结局
- Total lean mass(60 days)
- Blood glucose(60 days)
- Blood total cholesterol(60 days)
- Alanine transaminase(60 days)
- Body fat percentage(60 days)
- Blood insulin(60 days)
- Body mass index(60 days)
- Hip circumference(60 days)
- Gut microbiome(60 days)
- Blood low-density lipoprotein cholesterol(60 days)
- Waist circumference(60 days)
- Total fat mass(60 days)
- Blood pressure(60 days)
- Blood high-density lipoprotein cholesterol(60 days)
- Blood triglycerides(60 days)
- Aspartate aminotransferase(60 days)