A Pilot Study of the Probiotic L. Acidophilus (Strain TW01) on Gut Health, Body Composition, and Inflammation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Fecal butyrate
研究概览
简要总结
This is a pilot research study to investigate the effects of a probiotic supplement (L. acidophilus, strain TW01) on substances found in the stool and bloodstream, gut bacteria composition, body composition, as well as any relationship of these substances with markers of inflammation. Lactobacillus acidophilus is commonly found in a variety of fermented foods, including yogurt, cheese, and kefir, due to its ability to produce lactic acid and other substances. This bacterium is generally well-tolerated in healthy individuals and has a longstanding history of safe use. The investigators are doing this pilot study to see if a particular probiotic, called L. acidophilus (strain TW01) and isolated from fermented coffee grounds, can make a positive difference in human gut and overall health. Specifically, the investigators want to look at how this probiotic affects certain substances in human stool and blood, the makeup of the bacteria in the gut, and aspects of body composition. The investigators are also interested in whether these changes relate to markers of inflammation, which can tell us more about their impact on overall health. This probiotic strain has been shown in other studies to be safe and well tolerated, and the investigators hope our research will help us better understand how it works and whether it might support health in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years
- •Body mass index (BMI) between 28 kg/m2 and 40 kg/m2
- •Waist circumference ≥ 88 cm or 35 inches for women, ≥ 102 cm or 40 inches for men
- •Willing to consume experimental capsules daily
- •Willing to prepare and consume the delivered meal kits
- •Do not fit any
排除标准
- •Exclusion Criteria:
- •Self-reported history of immunodeficiency, major gastrointestinal surgery, renal or liver disease, diabetes, heart disease, stroke, peripheral artery/vascular disease, cancer, eating disorders, gut-associated pathologies, autoimmune diseases, pacemaker, thyroid disease, gallbladder disease, chronic inflammatory diseases, scleroderma, blood clotting disorders, intravenous drug use
- •Weight changes > 10% over the last 4 weeks
- •Oral antibiotics and/or probiotics use up to 1 month prior to study and during study
- •Currently taking GLP-1 analogues (e.g., Ozempic), anti-inflammatory medications (e.g., corticosteroids), daily use of nonsteroidal anti-inflammatory drugs (NSAIDs) (occasional use is permitted), medications which primarily affect blood clotting (e.g., warfarin), or any medications that suppress the immune system.
- •Dairy allergy
- •Currently pregnant or breast-feeding
研究组 & 干预措施
Placebo phase
Participants consume capsules containing only an inactive placebo (maltodextrin and magnesium stearate).
干预措施: Placebo (Dietary Supplement)
Probiotic phase
Participants consume capsules containing L. acidophilus (TW01) at 4×10^10 CFU/capsule (three capsules daily, totaling 1.2×10^11 CFU/day) plus a commercial fiber source (Fibersol-2).
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Fecal butyrate
时间窗: From baseline to the end of each 6-week intervention phase
Determine the effects of the probiotic on the short-chain fatty acid, butyrate (mmol/L), a marker of gut health in stool
次要结局
- Serum inflammation marker(From baseline to the end of each 6-week intervention phase)
- Body fat composition(From baseline to end of each 6-week intervention phase)
研究者
Christopher Blesso
Associate Professor
University of Connecticut