Comparison Study of Manapol and DaltonMax on Immune Function, Microbiome, and Related Variables in Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Microbiome analysis
研究概览
简要总结
The present study will compare the effect of Manapol to DaltonMax on select measures of health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as an active ingredient within various multi-nutrient products.
Immune function will be assessed using blood samples to determine white blood cell counts and distributions, and cytokine levels with/without lipopolysaccharide (LPS) challenge. Additionally, effects specific to antioxidant function and glucose regulation, glucose, insulin, lipid peroxidation, and advanced oxidation protein products will be observed. Antioxidant capacity will also be measured. as well as completion of weekly questionnaires regarding gut health, and microbiome analysis.
详细描述
Previous research has identified many beneficial properties of aloe vera extracts on health including the "induction of apoptosis, hepatoprotection, antioxidant, antibacterial, antidiabetic, antihyperglycemic, and anti-inflammatory effects". Further, aloe vera may ameliorate digestive issues such as irritable bowel syndrome, as indicated in a recent meta-analysis, although findings are somewhat inconsistent across studies and may be dependent on aloe form and dosage.
The present study will compare the effect of Manapol to DaltonMax on select measures of health. Currently, both ingredients are sold both as a stand-alone dietary supplement and as an active ingredient within various multi-nutrient products.
Immune function will be assessed using blood samples to determine white blood cell counts and distributions, and cytokine presence (IL-1β, IL-6, IL-10, TNF-alpha) with/without lipopolysaccharide (LPS) challenge. Additionally, aloe has been noted to have multiple effects specific to antioxidant function and glucose regulation, glucose, insulin, lipid peroxidation, and advanced oxidation protein products. An increase in blood antioxidant capacity was noted in an earlier study of Ambrotose, therefore antioxidant capacity will also be measured. As prior studies of aloe, coupled with anecdotal reports, provide evidence specific to a potential benefit to gut health, subjects will complete weekly questionnaires regarding gut health, and have a microbiome analysis performed.
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, Investigator)
盲法说明
Conditions will be provided in blinded containers (e.g. A,B,C).
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
- •no consumption of alcohol-containing beverages within 48 hours of testing
- •no consumption of caffeine-containing beverages within 48 hours of testing
- •no strenuous exercise within 48 hours of testing
- •be able to fast overnight (>10 hrs)
排除标准
- •self-reported active infection or illness of any kind
- •diagnosed with an autoimmune disease including but not limited to rheumatoid arthritis, lupus, Multiple sclerosis, Guillain-Barre syndrome, Psoriasis
- •diagnosed GI-related health problems
- •using tobacco products
- •allergic or hypersensitive to aloe vera
- •if female, pregnant or lactating
- •using antibiotics
- •using a medication/dietary supplement that alters immune or digestive function or that might otherwise impact study outcomes including, but not limited to supplements with immune, immunity, or defense in their name, immunosuppressants including Cyclosporines (Neoral®, Gengraf®, Sandimmune®), Tacrolimus (Prograf®, FK506), Mycophenolate mofetil (CellCept®), Prednisone, Azathioprine (Imuran®), Sirolimus (Rapamune®), Daclizumab and Basiliximab (Zenapax® and Simulect®), OKT3® (monoclonal antibody), Anti-Fungal Medications (Mycelex Troche®, Nystatin® Swish and Swallow, and Diflucan®), Antiviral Medications: Zovirax® (acyclovir), Cytovene® (ganciclovir), and Valcyte® (valganciclovir), Diuretics: Lasix® (furosemide), Antibiotics: Bactrim® (septra), Anti-Ulcer Medications: Prilosec® (omeprazole), Prevacid® (lansoprazole), Zantac® (ranitidine), Axid® (nizatidine), Carafate®(sucralfate), Pepcid®
研究组 & 干预措施
Manapol
1000 mg (Manapol only) Aloe Vera extract daily
干预措施: Aloe Vera Extract 1 (Dietary Supplement)
Dalton Max
1000 mg (Dalton Max only) Aloe Vera extract daily
干预措施: Aloe Vera Extract 2 (Dietary Supplement)
Placebo
Placebo (rice dextrin or similar) taken daily
干预措施: Control (Dietary Supplement)
结局指标
主要结局
Microbiome analysis
时间窗: on Day 30 of treatment
Subjects will submit a stool sample kit for microbiome analysis
Self-reported assessment of fatigue & associated variables
时间窗: Week 4 of treatment
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Subjects' perceived digestive/bowel health
时间窗: Week 4 of treatment
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Insulin
时间窗: on day 30 of treatment
Insulin levels in a blood sample will be measured
Cytokine Panel on LPS stimulated whole blood
时间窗: on day 30 of treatment
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS
Glucose
时间窗: on day 30 of treatment
Glucose levels in blood will be measured
Lipid peroxidation
时间窗: on day 30 of treatment
Lipid peroxiation in a blood sample will be quantified
Blood antioxidant capacity
时间窗: on day 30 of treatment
Blood antioxidant capacity will be quantified from a blood sample
White blood cell characterization
时间窗: on day 30 of treatment
A blood sample will be used to characterize the white blood cell population (cell count and distribution)
Cytokine Panel for plasma
时间窗: on day 30 of treatment
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
Advanced oxidation protein products
时间窗: on day 30 of treatment
Advanced oxidation protein products in a blood sample will be quantified
White blood cell characterization
时间窗: baseline
A blood sample will be used to characterize the white blood cell population (cell count and distribution)
Cytokine Panel for plasma
时间窗: baseline
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
Cytokine Panel on LPS stimulated whole blood
时间窗: baseline
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS
Glucose
时间窗: baseline
Glucose levels in blood will be measured
Insulin
时间窗: baseline
Insulin levels in a blood sample will be measured
Lipid peroxidation
时间窗: baseline
Lipid peroxiation in a blood sample will be quantified
Advanced oxidation protein products
时间窗: baseline
Advanced oxidation protein products in a blood sample will be quantified
Blood antioxidant capacity
时间窗: baseline
Blood antioxidant capacity will be quantified from a blood sample
Self-reported assessment of fatigue & associated variables
时间窗: baseline
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Self-reported assessment of fatigue & associated variables
时间窗: Week 1 of treatment
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Self-reported assessment of fatigue & associated variables
时间窗: Week 2 of treatment
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Self-reported assessment of fatigue & associated variables
时间窗: Week 3 of treatment
Subjects will self-report feelings by marking a scale from 0 (None) to 10 (Extreme) for different fatigue associated variables: Attentive, Tired, Alert, Groggy, Focuse, Sluggish, Energetic, Lethargic, Enthusiastic, Sore, Well-rested, Fatigue, Sickly, Mental Stress.
Subjects' perceived digestive/bowel health
时间窗: baseline
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Subjects' perceived digestive/bowel health
时间窗: Week 1 of treatment
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Subjects' perceived digestive/bowel health
时间窗: Week 2 of treatment
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Subjects' perceived digestive/bowel health
时间窗: Week 3 of treatment
Subjects will record their bowel movements/health using the Bristol stool chart weekly and questionnaire on their upper abdominal, lower abdominal, and other digestive symptoms on a scale 0 (no problem at all) to 9 (the worst it has ever been)
Microbiome analysis
时间窗: baseline
Subjects will submit a stool sample kit for microbiome analysis
次要结局
- Food Logs(on Day 30 of treatment)
- Resting Blood Pressure(on Day 30 of treatment)
- Resting Heart Rate(on day 30 of treatment)
- Food Logs(baseline)
- Resting Blood Pressure(baseline)
- Resting Heart Rate(baseline)
研究者
Richard Bloomer
Dean of the College of Health Sciences
University of Memphis