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

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.

Study Overview

• Status: Completed
• Conditions: Microbiome; Immune Function
• Intervention / Treatment: Dietary supplement: Control; Dietary supplement: Aloe Vera Extract 1; Dietary supplement: Aloe Vera Extract 2

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacquelyn Pence, PhD; Phone Number: 901-678-1547; Email: jpence1@memphis.edu

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38156
      • Center for Nutraceutical and Dietary Supplement Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo (rice dextrin or similar) taken daily	Dietary supplement: Control; 2 capsules taken daily for 30 days
Experimental: Manapol; 1000 mg (Manapol only) Aloe Vera extract daily	Dietary supplement: Aloe Vera Extract 1; 2 capsules taken daily for 30 days
Experimental: Dalton Max; 1000 mg (Dalton Max only) Aloe Vera extract daily	Dietary supplement: Aloe Vera Extract 2; 2 capsules taken daily for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
White blood cell characterization	A blood sample will be used to characterize the white blood cell population (cell count and distribution)	baseline
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
Cytokine Panel for plasma	IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma	baseline
Cytokine Panel for plasma	IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma	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	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	on day 30 of treatment
Glucose	Glucose levels in blood will be measured	baseline
Glucose	Glucose levels in blood will be measured	on day 30 of treatment
Insulin	Insulin levels in a blood sample will be measured	baseline
Insulin	Insulin levels in a blood sample will be measured	on day 30 of treatment
Lipid peroxidation	Lipid peroxiation in a blood sample will be quantified	baseline
Lipid peroxidation	Lipid peroxiation in a blood sample will be quantified	on day 30 of treatment
Advanced oxidation protein products	Advanced oxidation protein products in a blood sample will be quantified	baseline
Advanced oxidation protein products	Advanced oxidation protein products in a blood sample will be quantified	on day 30 of treatment
Blood antioxidant capacity	Blood antioxidant capacity will be quantified from a blood sample	baseline
Blood antioxidant capacity	Blood antioxidant capacity will be quantified from a blood sample	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.	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.	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.	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.	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.	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)	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)	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)	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)	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)	Week 4 of treatment
Microbiome analysis	Subjects will submit a stool sample kit for microbiome analysis	baseline
Microbiome analysis	Subjects will submit a stool sample kit for microbiome analysis	on Day 30 of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food Logs	Subjects will record their dietary consumption for the 5 days leading up to each test visit	baseline
Food Logs	Subjects will record their dietary consumption for the 5 days leading up to each test visit	on Day 30 of treatment
Resting Blood Pressure	Blood pressure will be measured following a 10 min rest using an automated system	baseline
Resting Blood Pressure	Blood pressure will be measured following a 10 min rest using an automated system	on Day 30 of treatment
Resting Heart Rate	Heart rate will be measured following a 10 min rest using an automated system	baseline
Resting Heart Rate	Heart rate will be measured following a 10 min rest using an automated system	on day 30 of treatment

Collaborators and Investigators

• Sponsor: University of Memphis
• Collaborators: Mannatech
• Investigators: Principal Investigator: Richard Bloomer, PhD, University of Memphis

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Aloe Vera extract; Manapol; Dalton Max
• Other Study ID Numbers: PRO-FY2022-131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No