Comparison Study of Manapol & DaltonMax on Immune Function, Microbiome, &

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05510050
Study type	Interventional
Source	University of Memphis
Contact
Status	Completed
Phase	N/A
Start date	May 13, 2022
Completion date	March 3, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms