NCT05510050

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

August 19, 2022

Last Update Submit

September 22, 2023

Conditions

MicrobiomeImmune Function

Keywords

Aloe Vera extractManapolDalton Max

Outcome Measures

Primary Outcomes (28)

  • 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 Outcomes (6)

  • Food Logs

    baseline

  • Food Logs

    on Day 30 of treatment

  • Resting Blood Pressure

    baseline

  • Resting Blood Pressure

    on Day 30 of treatment

  • Resting Heart Rate

    baseline

  • +1 more secondary outcomes

Study Arms (3)

Manapol

EXPERIMENTAL

1000 mg (Manapol only) Aloe Vera extract daily

Dietary Supplement: Aloe Vera Extract 1

Dalton Max

EXPERIMENTAL

1000 mg (Dalton Max only) Aloe Vera extract daily

Dietary Supplement: Aloe Vera Extract 2

Placebo

PLACEBO COMPARATOR

Placebo (rice dextrin or similar) taken daily

Dietary Supplement: Control

Interventions

Aloe Vera Extract 1DIETARY_SUPPLEMENT

2 capsules taken daily for 30 days

Manapol
ControlDIETARY_SUPPLEMENT

2 capsules taken daily for 30 days

Placebo
Aloe Vera Extract 2DIETARY_SUPPLEMENT

2 capsules taken daily for 30 days

Dalton Max

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38156, United States

Location

Study Officials

  • Richard Bloomer, PhD

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Conditions will be provided in blinded containers (e.g. A,B,C).
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of the College of Health Sciences

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 22, 2022

Study Start

May 13, 2022

Primary Completion

November 3, 2022

Study Completion

March 3, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)