An interventional study of Aloe Vera Extract 1 and Control in Microbiome and Immune Function, sponsored by University of Memphis. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by University of Memphis · Not applicable, Interventional, and Basic science
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.
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.
University of Memphis is the lead sponsor of 44 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1000 mg (Manapol only) Aloe Vera extract daily
Dietary Supplement: Aloe Vera Extract 1
1000 mg (Dalton Max only) Aloe Vera extract daily
Dietary Supplement: Aloe Vera Extract 2
Placebo (rice dextrin or similar) taken daily
Dietary Supplement: Control
2 capsules taken daily for 30 days
2 capsules taken daily for 30 days
2 capsules taken daily for 30 days
White blood cell characterization
A blood sample will be used to characterize the white blood cell population (cell count and distribution)
Time frame: baseline
White blood cell characterization
A blood sample will be used to characterize the white blood cell population (cell count and distribution)
Time frame: on day 30 of treatment
Cytokine Panel for plasma
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
Time frame: baseline
Cytokine Panel for plasma
IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma
Time frame: 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
Time frame: 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
Time frame: on day 30 of treatment
Glucose
Glucose levels in blood will be measured
Time frame: baseline
Glucose
Glucose levels in blood will be measured
Time frame: on day 30 of treatment
Insulin
Insulin levels in a blood sample will be measured
Time frame: baseline
Insulin
Insulin levels in a blood sample will be measured
Time frame: on day 30 of treatment
Lipid peroxidation
Lipid peroxiation in a blood sample will be quantified
Time frame: baseline
Lipid peroxidation
Lipid peroxiation in a blood sample will be quantified
Time frame: on day 30 of treatment
Advanced oxidation protein products
Advanced oxidation protein products in a blood sample will be quantified
Time frame: baseline
Advanced oxidation protein products
Advanced oxidation protein products in a blood sample will be quantified
Time frame: on day 30 of treatment
Blood antioxidant capacity
Blood antioxidant capacity will be quantified from a blood sample
Time frame: baseline
Blood antioxidant capacity
Blood antioxidant capacity will be quantified from a blood sample
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Week 4 of treatment
Microbiome analysis
Subjects will submit a stool sample kit for microbiome analysis
Time frame: baseline
Microbiome analysis
Subjects will submit a stool sample kit for microbiome analysis
Time frame: on Day 30 of treatment
Food Logs
Subjects will record their dietary consumption for the 5 days leading up to each test visit
Time frame: baseline
Food Logs
Subjects will record their dietary consumption for the 5 days leading up to each test visit
Time frame: on Day 30 of treatment
Resting Blood Pressure
Blood pressure will be measured following a 10 min rest using an automated system
Time frame: baseline
Resting Blood Pressure
Blood pressure will be measured following a 10 min rest using an automated system
Time frame: on Day 30 of treatment
Resting Heart Rate
Heart rate will be measured following a 10 min rest using an automated system
Time frame: baseline
Resting Heart Rate
Heart rate will be measured following a 10 min rest using an automated system
Time frame: on day 30 of treatment
Plan to share: No
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University of Memphis