Clinical trial NCT05510050: Comparison Study of Manapol and DaltonMax on Immune Function, Microbiome, and Related Variables in Men and Women
Official title: Comparison Study of Manapol and DaltonMax on Immune Function, Microbiome, and Related Variables in Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiome
Immune Function
Keywords: Aloe Vera extract
Manapol
Dalton Max
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: Mannatech
First posted: 2022-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo controlled
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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®

Primary outcomes:
measure: White blood cell characterization
timeFrame: baseline
measure: White blood cell characterization
timeFrame: on day 30 of treatment
measure: Cytokine Panel for plasma
timeFrame: baseline
measure: Cytokine Panel for plasma
timeFrame: on day 30 of treatment
measure: Cytokine Panel on LPS stimulated whole blood
timeFrame: baseline
measure: Cytokine Panel on LPS stimulated whole blood
timeFrame: on day 30 of treatment
measure: Glucose
timeFrame: baseline
measure: Glucose
timeFrame: on day 30 of treatment
measure: Insulin
timeFrame: baseline
measure: Insulin
timeFrame: on day 30 of treatment
measure: Lipid peroxidation
timeFrame: baseline
measure: Lipid peroxidation
timeFrame: on day 30 of treatment
measure: Advanced oxidation protein products
timeFrame: baseline
measure: Advanced oxidation protein products
timeFrame: on day 30 of treatment
measure: Blood antioxidant capacity
timeFrame: baseline
measure: Blood antioxidant capacity
timeFrame: on day 30 of treatment
measure: Self-reported assessment of fatigue & associated variables
timeFrame: baseline
measure: Self-reported assessment of fatigue & associated variables
timeFrame: Week 1 of treatment
measure: Self-reported assessment of fatigue & associated variables
timeFrame: Week 2 of treatment
measure: Self-reported assessment of fatigue & associated variables
timeFrame: Week 3 of treatment
measure: Self-reported assessment of fatigue & associated variables
timeFrame: Week 4 of treatment
measure: Subjects' perceived digestive/bowel health
timeFrame: baseline
measure: Subjects' perceived digestive/bowel health
timeFrame: Week 1 of treatment
measure: Subjects' perceived digestive/bowel health
timeFrame: Week 2 of treatment
measure: Subjects' perceived digestive/bowel health
timeFrame: Week 3 of treatment
measure: Subjects' perceived digestive/bowel health
timeFrame: Week 4 of treatment
measure: Microbiome analysis
timeFrame: baseline
measure: Microbiome analysis
timeFrame: on Day 30 of treatment
Secondary outcomes:
measure: Food Logs
timeFrame: baseline
measure: Food Logs
timeFrame: on Day 30 of treatment
measure: Resting Blood Pressure
timeFrame: baseline
measure: Resting Blood Pressure
timeFrame: on Day 30 of treatment
measure: Resting Heart Rate
timeFrame: baseline
measure: Resting Heart Rate
timeFrame: on day 30 of treatment
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: