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Completed

NCT Number: NCT05510050

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.

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Key information

Conditions

Microbiome Immune Function

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38156, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Aloe Vera Extract 1

Dietary Supplement

2 capsules taken daily for 30 days

Control

Dietary Supplement

2 capsules taken daily for 30 days

Aloe Vera Extract 2

Dietary Supplement

2 capsules taken daily for 30 days

Primary outcomes

  1. White blood cell characterization

    Time frame: baseline

    A blood sample will be used to characterize the white blood cell population (cell count and distribution)

  2. White blood cell characterization

    Time frame: on day 30 of treatment

    A blood sample will be used to characterize the white blood cell population (cell count and distribution)

  3. Cytokine Panel for plasma

    Time frame: baseline

    IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma

  4. Cytokine Panel for plasma

    Time frame: on day 30 of treatment

    IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified from plasma

  5. Cytokine Panel on LPS stimulated whole blood

    Time frame: baseline

    IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS

  6. Cytokine Panel on LPS stimulated whole blood

    Time frame: on day 30 of treatment

    IL-1beta, IL-6, IL-10, and TNF-alpha will be quantified on whole blood treated with LPS

  7. Glucose

    Time frame: baseline

    Glucose levels in blood will be measured

  8. Glucose

    Time frame: on day 30 of treatment

    Glucose levels in blood will be measured

  9. Insulin

    Time frame: baseline

    Insulin levels in a blood sample will be measured

  10. Insulin

    Time frame: on day 30 of treatment

    Insulin levels in a blood sample will be measured

  11. Lipid peroxidation

    Time frame: baseline

    Lipid peroxiation in a blood sample will be quantified

  12. Lipid peroxidation

    Time frame: on day 30 of treatment

    Lipid peroxiation in a blood sample will be quantified

  13. Advanced oxidation protein products

    Time frame: baseline

    Advanced oxidation protein products in a blood sample will be quantified

  14. Advanced oxidation protein products

    Time frame: on day 30 of treatment

    Advanced oxidation protein products in a blood sample will be quantified

  15. Blood antioxidant capacity

    Time frame: baseline

    Blood antioxidant capacity will be quantified from a blood sample

  16. Blood antioxidant capacity

    Time frame: on day 30 of treatment

    Blood antioxidant capacity will be quantified from a blood sample

  17. Self-reported assessment of fatigue & associated variables

    Time frame: baseline

    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.

  18. Self-reported assessment of fatigue & associated variables

    Time frame: Week 1 of treatment

    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.

  19. Self-reported assessment of fatigue & associated variables

    Time frame: Week 2 of treatment

    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.

  20. Self-reported assessment of fatigue & associated variables

    Time frame: Week 3 of treatment

    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.

  21. Self-reported assessment of fatigue & associated variables

    Time frame: Week 4 of treatment

    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.

  22. Subjects' perceived digestive/bowel health

    Time frame: baseline

    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)

  23. Subjects' perceived digestive/bowel health

    Time frame: Week 1 of treatment

    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)

  24. Subjects' perceived digestive/bowel health

    Time frame: Week 2 of treatment

    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)

  25. Subjects' perceived digestive/bowel health

    Time frame: Week 3 of treatment

    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)

  26. Subjects' perceived digestive/bowel health

    Time frame: Week 4 of treatment

    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)

  27. Microbiome analysis

    Time frame: baseline

    Subjects will submit a stool sample kit for microbiome analysis

  28. Microbiome analysis

    Time frame: on Day 30 of treatment

    Subjects will submit a stool sample kit for microbiome analysis

Secondary outcomes

  1. Food Logs

    Time frame: baseline

    Subjects will record their dietary consumption for the 5 days leading up to each test visit

  2. Food Logs

    Time frame: on Day 30 of treatment

    Subjects will record their dietary consumption for the 5 days leading up to each test visit

  3. Resting Blood Pressure

    Time frame: baseline

    Blood pressure will be measured following a 10 min rest using an automated system

  4. Resting Blood Pressure

    Time frame: on Day 30 of treatment

    Blood pressure will be measured following a 10 min rest using an automated system

  5. Resting Heart Rate

    Time frame: baseline

    Heart rate will be measured following a 10 min rest using an automated system

  6. Resting Heart Rate

    Time frame: on day 30 of treatment

    Heart rate will be measured following a 10 min rest using an automated system

Sponsors and collaborators

Lead sponsor

University of Memphis

Other

Collaborators

  • Mannatech

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 22, 2022
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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