NCT05510050

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Memphis · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Microbiome
• Immune Function

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Aloe Vera Extract 1	2 capsules taken daily for 30 days
DIETARY_SUPPLEMENT	Control	2 capsules taken daily for 30 days
DIETARY_SUPPLEMENT	Aloe Vera Extract 2	2 capsules taken daily for 30 days

Timeline

• Start date: 2022-05-13
• Primary completion: 2022-11-03
• Completion: 2023-03-03
• First posted: 2022-08-22
• Last updated: 2023-09-26

Locations

1 site across 1 country: United States