Immune Function, Microbiome
Conditions
Keywords
Aloe Vera extract, Manapol, Dalton Max
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTAloe Vera Extract 1
2 capsules taken daily for 30 days
DIETARY_SUPPLEMENTControl
2 capsules taken daily for 30 days
DIETARY_SUPPLEMENTAloe Vera Extract 2
2 capsules taken daily for 30 days
Sponsors
Mannatech
University of Memphis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Conditions will be provided in blinded containers (e.g. A,B,C).
Intervention model description
Randomized, double-blind, placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome analysis | baseline | Subjects will submit a stool sample kit for microbiome analysis |
| Blood antioxidant capacity | baseline | 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. |
| 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) |
| White blood cell characterization | baseline | 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 on LPS stimulated whole blood | baseline | 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 |
| Insulin | baseline | Insulin levels in a blood sample will be measured |
| Lipid peroxidation | baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting Blood Pressure | baseline | 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 |
| Food Logs | baseline | Subjects will record their dietary consumption for the 5 days leading up to each test visit |
Countries
United States
Outcome results
None listed