Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Microbial Population and Concentration
研究概览
简要总结
This study evaluates the effects of combination probiotic, prebiotic, and enzyme supplementation on the colonic microbiome of individuals with GI symptoms (e.g. diarrhea, constipation, increased gas). Half of the participants will receive the placebo while the other half will receive the supplement for 28 days.
详细描述
The purpose of this research is to identify if there is a relationship between GlutenShield, a combination prebiotic, probiotic, and enzyme supplement, and the gut environment.
The study will be a split, 28-day randomized, partially blinded design. Subjects will be randomly assigned to one of two groups. One group will complete a 28-day treatment period with GlutenShield taken 3x/day with meals. The other group will complete a 28-day placebo period with the placebo taken 3x/day with meals. The placebo will contain Avicel (cellulose) and bentonite powder (to have a similar color as GlutenShield). Participants will be blinded to which group/ treatment they are being given. Serum and fecal samples will be collected at baseline and on day 29. Participants will also complete a gastrointestinal symptoms questionnaire, a food frequency questionnaire and a psychosocial measures of self questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who express gastrointestinal symptoms more than three times per week as identified through the Gastrointestinal Symptom Questionnaire (such as abdominal pain/ discomfort, heartburn, acid regurgitation, bloating, nausea and vomiting, abdominal distention, eructation (burping), increased gas, decreased passage of stools, increased passage of stools, loose stools, hard stools, urgent need for defecation, or feeling of incomplete evacuation)
- •Healthy with few health complications
- •Adults ages 18 or older
排除标准
- •Anyone under the age of 18
- •Individuals diagnosed with celiacs, IBS, Crohn's disease, ulcerative colitis, or short bowel syndrome
- •Individuals who have previously taken GlutenShield
- •Individuals who are currently taking prebiotics, probiotics, enzymes, non-steroidal anti-inflammatory drugs, fish oil, and/or fiber supplements (unless use is halted in the voluntary 2-week washout period prior to the study)
- •Individuals who are pregnant or intend to become pregnant during the duration of the study
研究组 & 干预措施
GlutenShield
3 capsules of GlutenShield supplement/day for 28 days
干预措施: GlutenShield (Dietary Supplement)
Placebo
3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days
干预措施: Placebo (Other)
结局指标
主要结局
Change in Microbial Population and Concentration
时间窗: Baseline and Day 29
Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing).
Change in Inflammation
时间窗: Baseline and Day 29
Measuring change in serum markers of inflammation (IgA and IgG, GM-CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α) over 28 days. Values will be used to determine a change in overall inflammatory status.
Change in Fermentation Profile- Short Chain Fatty Acid Concentration
时间窗: Baseline and Day 29
Measuring change short chain fatty acid concentrations in fecal matter (analyzed using gas chromatography) from baseline to after 28 days.
次要结局
- Change in Oxidative Stress(Baseline and Day 29)
- Changes in Psychosocial Measures of Self(Baseline and Day 29)
- Physical Activity(Baseline)
- Dietary Intake(Baseline)
- Changes in Adipokine Response(Baseline and Day 29)
研究者
Kaitlyn Webb
Graduate Student in Clinical Nutrition
East Tennessee State University