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

Microbiome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05510050
• Other study ID #: PRO-FY2022-131
• Status: Completed
• Phase: N/A
• Start date: May 13, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: September 2023
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 3, 2023
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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®

Related Conditions & MeSH terms

• Immune Function
• Microbiome

Intervention

Dietary Supplement:
• Aloe Vera Extract 1
2 capsules taken daily for 30 days
• Control
2 capsules taken daily for 30 days
• Aloe Vera Extract 2
2 capsules taken daily for 30 days

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Research	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	Mannatech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	White blood cell characterization	A blood sample will be used to characterize the white blood cell population (cell count and distribution)	baseline
Primary	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
Primary	Cytokine Panel for plasma	IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma	baseline
Primary	Cytokine Panel for plasma	IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma	on day 30 of treatment
Primary	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
Primary	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
Primary	Glucose	Glucose levels in blood will be measured	baseline
Primary	Glucose	Glucose levels in blood will be measured	on day 30 of treatment
Primary	Insulin	Insulin levels in a blood sample will be measured	baseline
Primary	Insulin	Insulin levels in a blood sample will be measured	on day 30 of treatment
Primary	Lipid peroxidation	Lipid peroxiation in a blood sample will be quantified	baseline
Primary	Lipid peroxidation	Lipid peroxiation in a blood sample will be quantified	on day 30 of treatment
Primary	Advanced oxidation protein products	Advanced oxidation protein products in a blood sample will be quantified	baseline
Primary	Advanced oxidation protein products	Advanced oxidation protein products in a blood sample will be quantified	on day 30 of treatment
Primary	Blood antioxidant capacity	Blood antioxidant capacity will be quantified from a blood sample	baseline
Primary	Blood antioxidant capacity	Blood antioxidant capacity will be quantified from a blood sample	on day 30 of treatment
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Microbiome analysis	Subjects will submit a stool sample kit for microbiome analysis	baseline
Primary	Microbiome analysis	Subjects will submit a stool sample kit for microbiome analysis	on Day 30 of treatment
Secondary	Food Logs	Subjects will record their dietary consumption for the 5 days leading up to each test visit	baseline
Secondary	Food Logs	Subjects will record their dietary consumption for the 5 days leading up to each test visit	on Day 30 of treatment
Secondary	Resting Blood Pressure	Blood pressure will be measured following a 10 min rest using an automated system	baseline
Secondary	Resting Blood Pressure	Blood pressure will be measured following a 10 min rest using an automated system	on Day 30 of treatment
Secondary	Resting Heart Rate	Heart rate will be measured following a 10 min rest using an automated system	baseline
Secondary	Resting Heart Rate	Heart rate will be measured following a 10 min rest using an automated system	on day 30 of treatment