Comparison Study of Manapol and DaltonMax on Immune Function, Microbiome, and Related Variables in Men and Women

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.

• Aloe Vera Extract 1 (Dietary supplement): 2 capsules taken daily for 30 days
• Control (Dietary supplement): 2 capsules taken daily for 30 days
• Aloe Vera Extract 2 (Dietary supplement): 2 capsules taken daily for 30 days

Primary outcomes

• White blood cell characterization [baseline]: A blood sample will be used to characterize the white blood cell population (cell count and distribution)
• White blood cell characterization [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 [baseline]: IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
• Cytokine Panel for plasma [on day 30 of treatment]: IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
• Cytokine Panel on LPS stimulated whole blood [baseline]: IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS
• Cytokine Panel on LPS stimulated whole blood [on day 30 of treatment]: IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS
• Glucose [baseline]: Glucose levels in blood will be measured
• Glucose [on day 30 of treatment]: Glucose levels in blood will be measured
• Insulin [baseline]: Insulin levels in a blood sample will be measured
• Insulin [on day 30 of treatment]: Insulin levels in a blood sample will be measured
• Lipid peroxidation [baseline]: Lipid peroxiation in a blood sample will be quantified
• Lipid peroxidation [on day 30 of treatment]: Lipid peroxiation in a blood sample will be quantified
• Advanced oxidation protein products [baseline]: Advanced oxidation protein products in a blood sample will be quantified
• Advanced oxidation protein products [on day 30 of treatment]: Advanced oxidation protein products in a blood sample will be quantified
• Blood antioxidant capacity [baseline]: Blood antioxidant capacity will be quantified from a blood sample
• Blood antioxidant capacity [on day 30 of treatment]: Blood antioxidant capacity will be quantified from a blood sample
• Self-reported assessment of fatigue & associated variables [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 [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 [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 [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.
• Self-reported assessment of fatigue & associated variables [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 [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 [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 [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 [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)
• Subjects' perceived digestive/bowel health [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)
• Microbiome analysis [baseline]: Subjects will submit a stool sample kit for microbiome analysis
• Microbiome analysis [on Day 30 of treatment]: Subjects will submit a stool sample kit for microbiome analysis

Secondary outcomes

• Food Logs [baseline]: Subjects will record their dietary consumption for the 5 days leading up to each test visit
• Food Logs [on Day 30 of treatment]: Subjects will record their dietary consumption for the 5 days leading up to each test visit
• Resting Blood Pressure [baseline]: Blood pressure will be measured following a 10 min rest using an automated system
• Resting Blood Pressure [on Day 30 of treatment]: Blood pressure will be measured following a 10 min rest using an automated system
• Resting Heart Rate [baseline]: Heart rate will be measured following a 10 min rest using an automated system
• Resting Heart Rate [on day 30 of treatment]: Heart rate will be measured following a 10 min rest using an automated system

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

Inclusion Criteria:

* 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)

Exclusion Criteria:

* self-reported active infection or illness of any kind
* diabetic
* 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®

• Richard Bloomer, PhD, Principal investigator, University of Memphis