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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Microbiome, Immune Function

Intervention / Treatment
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* Dietary Supplement: Aloe Vera Extract 1
* Dietary Supplement: Control
* Dietary Supplement: Aloe Vera Extract 2


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, placebo controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manapol<br>1000 mg (Manapol only) Aloe Vera extract daily | Dietary Supplement: Aloe Vera Extract 1<br>* 2 capsules taken daily for 30 days<br>|
| Experimental: Dalton Max<br>1000 mg (Dalton Max only) Aloe Vera extract daily | Dietary Supplement: Aloe Vera Extract 2<br>* 2 capsules taken daily for 30 days<br>|
| Placebo Comparator: Placebo<br>Placebo (rice dextrin or similar) taken daily | Dietary Supplement: Control<br>* 2 capsules taken daily for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| White blood cell characterization | A blood sample will be used to characterize the white blood cell population (cell count and distribution) | baseline | 
| White blood cell characterization | A blood sample will be used to characterize the white blood cell population (cell count and distribution) | on day 30 of treatment | 
| Cytokine Panel for plasma | IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma | baseline | 
| Cytokine Panel for plasma | IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma | on day 30 of treatment | 
| Cytokine Panel on LPS stimulated whole blood | IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS | baseline | 
| Cytokine Panel on LPS stimulated whole blood | IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS | on day 30 of treatment | 
| Glucose | Glucose levels in blood will be measured | baseline | 
| Glucose | Glucose levels in blood will be measured | on day 30 of treatment | 
| Insulin | Insulin levels in a blood sample will be measured | baseline | 
| Insulin | Insulin levels in a blood sample will be measured | on day 30 of treatment | 
| Lipid peroxidation | Lipid peroxiation in a blood sample will be quantified | baseline | 
| Lipid peroxidation | Lipid peroxiation in a blood sample will be quantified | on day 30 of treatment | 
| Advanced oxidation protein products | Advanced oxidation protein products in a blood sample will be quantified | baseline | 
| Advanced oxidation protein products | Advanced oxidation protein products in a blood sample will be quantified | on day 30 of treatment | 
| Blood antioxidant capacity | Blood antioxidant capacity will be quantified from a blood sample | baseline | 
| Blood antioxidant capacity | Blood antioxidant capacity will be quantified from a blood sample | on day 30 of treatment | 
| Self-reported assessment of fatigue & associated variables | 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. | baseline | 
| Self-reported assessment of fatigue & associated variables | 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. | Week 1 of treatment | 
| Self-reported assessment of fatigue & associated variables | 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. | Week 2 of treatment | 
| Self-reported assessment of fatigue & associated variables | 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. | Week 3 of treatment | 
| Self-reported assessment of fatigue & associated variables | 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. | Week 4 of treatment | 
| Subjects' perceived digestive/bowel health | 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) | baseline | 
| Subjects' perceived digestive/bowel health | 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) | Week 1 of treatment | 
| Subjects' perceived digestive/bowel health | 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) | Week 2 of treatment | 
| Subjects' perceived digestive/bowel health | 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) | Week 3 of treatment | 
| Subjects' perceived digestive/bowel health | 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) | Week 4 of treatment | 
| Microbiome analysis | Subjects will submit a stool sample kit for microbiome analysis | baseline | 
| Microbiome analysis | Subjects will submit a stool sample kit for microbiome analysis | on Day 30 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Logs | Subjects will record their dietary consumption for the 5 days leading up to each test visit | baseline | 
| Food Logs | Subjects will record their dietary consumption for the 5 days leading up to each test visit | on Day 30 of treatment | 
| Resting Blood Pressure | Blood pressure will be measured following a 10 min rest using an automated system | baseline | 
| Resting Blood Pressure | Blood pressure will be measured following a 10 min rest using an automated system | on Day 30 of treatment | 
| Resting Heart Rate | Heart rate will be measured following a 10 min rest using an automated system | baseline | 
| Resting Heart Rate | Heart rate will be measured following a 10 min rest using an automated system | on day 30 of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aloe Vera extract, Manapol, Dalton Max