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Trial record 76 of 487 for:    ALS (Amyotrophic Lateral Sclerosis)

ALS Reversals - Lunasin Regimen

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ClinicalTrials.gov Identifier: NCT02709330
Recruitment Status : Completed
First Posted : March 16, 2016
Results First Posted : December 13, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Bedlack, M.D., Ph.D., Duke University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition ALS (Amyotrophic Lateral Sclerosis)
Interventions Drug: Lunasin Regimen
Other: Historical control
Enrollment 60
Recruitment Details Subjects were recruited from the clinic patient population and outside advertisements and postings. Recruitment began 3/28/2016 and ended 9/14/16 once 50 subjects had been enrolled. Study visits were conducted at the Duke ALS clinic and via phone contacts.
Pre-assignment Details An additional 10 subjects were consented specifically as controls for outcome measure 2 and not included in the treatment group (Lunasin regimen).
Arm/Group Title Lunasin Regimen Control
Hide Arm/Group Description

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Subjects were consented specifically as controls for outcome measure 2 and not included in the treatment (Lunasin regimen) group.
Period Title: Overall Study
Started 50 10
Completed 37 10
Not Completed 13 0
Reason Not Completed
Death             5             0
Lost to Follow-up             2             0
Physician Decision             2             0
Withdrawal by Subject             4             0
Arm/Group Title Lunasin Regimen
Hide Arm/Group Description

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
Baseline data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
60  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
21
  42.0%
Male
29
  58.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Hispanic or Latino
1
   2.0%
Not Hispanic or Latino
49
  98.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   6.0%
White
47
  94.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 50 participants
50
 100.0%
1.Primary Outcome
Title Change in Revised ALS Functional Rating Scale (ALSFRS-R)
Hide Description ALSFRS-R is a quickly administered (five minute) ordinal rating scale used to determine patient's assessment of their capability and independence in 13 functional activities. All 13 activities are relevant in ALS. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability, with a total score of 52 points. Reported is the rate of change in total points per month.
Time Frame Screening/baseline - 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant deleted PLM account; 2 others did not enter ALSFRS-R data.
Arm/Group Title Lunasin Regimen
Hide Arm/Group Description:

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: points per month
0.44  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lunasin Regimen
Comments Matched historical controls will be identified from the PatientsLikeMe database.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Kolmogorov-Smirnov Test
Comments [Not Specified]
2.Secondary Outcome
Title Change in H3 Histone Acetylation
Hide Description Participants, ALS controls (not on Lunasin) and healthy controls (not on Lunasin) had blood drawn at baseline and 1 month time points. Histones were extracted from blood cells. Western blots were used to look at specific histone acetylation patterns that Lunasin had reportedly altered in cell cultures (H3K9K14ac2 and H4K5K8K12K16). Integrated density values for AcH3 protein bands were normalized for total H3. Percent H3 values for the 1 month time point were normalized to that of the baseline visit. Results were analyzed by one-way ANOVA.
Time Frame Screening/baseline, Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
Lunasin regimen: 20 of 50 enrolled participants did not have sufficient sample. Five ALS control subjects (not on Lunasin) and five healthy control subjects (not on Lunasin) were also consented specifically for this analysis. One of the healthy controls did not have sufficient sample.
Arm/Group Title Lunasin Regimen ALS Controls Healthy Controls
Hide Arm/Group Description:

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Individuals with ALS who are not on Lunasin.
Healthy individuals who are not on Lunasin.
Overall Number of Participants Analyzed 30 5 4
Mean (Standard Deviation)
Unit of Measure: percentage of baseline
0.993  (0.53) 1.252  (0.74) 1.795  (1.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lunasin Regimen, ALS Controls, Healthy Controls
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0748
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Percent Agreement Between the Weights Obtained by Patients and Study Coordinator
Hide Description To confirm that participants can accurately measure their own weight, even as they become more disabled by ALS, the investigators will compare the participant-generated weight with the weight obtained by the study coordinator at the Month 1 and Month 12 visits. A simple description of the accuracy (percent agreement between the weights) will be used.
Time Frame Month 1, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with both self-obtained weight and weight obtained by the study coordinator available.
Arm/Group Title Lunasin Regimen
Hide Arm/Group Description:

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Overall Number of Participants Analyzed 49
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of agreement
Month 1 Number Analyzed 49 participants
99.47
(99.07 to 99.70)
Month 12 Number Analyzed 25 participants
99.05
(94.28 to 99.58)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lunasin Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Lin's Concordance
Comments [Not Specified]
4.Secondary Outcome
Title Enrollment Rate
Hide Description Rate of enrollment in reaching the 50 participants required to fill the trial.
Time Frame Screening/baseline - Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lunasin Regimen
Hide Arm/Group Description:

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants per month
9.1
5.Secondary Outcome
Title Retention Rate
Hide Description Percentage of surviving participants who completed the month 12 visit.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lunasin Regimen
Hide Arm/Group Description:

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
84
6.Secondary Outcome
Title Frequency of ALS Reversals
Hide Description The percentage of enrolled participants experiencing an ALSFRS-R improvement of at least 4 points lasting at least 12 months.
Time Frame Screening/baseline - Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lunasin Regimen
Hide Arm/Group Description:

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
0
7.Secondary Outcome
Title ALSFRS-R Accuracy
Hide Description To confirm that participants can accurately measure their own ALS Functional Rating Scale (Revised, ALSFRS-R), the investigators will compare the ALSFRS-R obtained by the coordinator with that obtained by the participants themselves at the Month 1 Visit. Correlational analysis between these 2 scores will be performed with Spearman's rho.
Time Frame Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
2 participants did not provide month 1 scores.
Arm/Group Title Lunasin Regimen
Hide Arm/Group Description:

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

Overall Number of Participants Analyzed 48
Mean (95% Confidence Interval)
Unit of Measure: percentage of accuracy
99.39
(98.92 to 99.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lunasin Regimen
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments [Not Specified]
Method Lin's Concordance
Comments [Not Specified]
Time Frame 12 months
Adverse Event Reporting Description Adverse Event data were not collected for the 5 ALS control subjects and 5 healthy control subjects.
 
Arm/Group Title Lunasin Regimen
Hide Arm/Group Description

The Lunasin regimen consists of:

  • LunaRich X Capsules (12 capsules per day)
  • Reliv NOW – a mixture of ‘vitamins, minerals and super-powered antioxidants’ (3 scoops per day)
  • Pro-Vantage – a mixture of ‘soy protein, medium chain triglycerides, creatine, CoQ10 and supercharged amino acids’ (2 scoops per day)

It will be suggested that patients open the LunaRich X capsules and mix the contents of these as well as the other 2 ingredients in water to make a shake. If patients do not tolerate advancing to the next dosage, they will be asked to drop back to the highest dosage they could tolerate.

Lunasin Regimen: LunaRich X Capsules, Reliv Now, ProVantage

All-Cause Mortality
Lunasin Regimen
Affected / at Risk (%)
Total   5/50 (10.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lunasin Regimen
Affected / at Risk (%)
Total   13/50 (26.00%) 
Cardiac disorders   
Death from Cardiac Arrest *  1/50 (2.00%) 
Cardiac Arrest *  1/50 (2.00%) 
Gastrointestinal disorders   
Obstipation/Fecal Imaction *  2/50 (4.00%) 
Infections and infestations   
PEG Infection *  1/50 (2.00%) 
C. Diff Infection *  1/50 (2.00%) 
Mumps Infection *  1/50 (2.00%) 
Pneumonia *  1/50 (2.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast Cancer *  1/50 (2.00%) 
Nervous system disorders   
Death from ALS progression *  3/50 (6.00%) 
Death from Intracerebral Hemorrhage *  1/50 (2.00%) 
Intracerebral Hemorrhage *  1/50 (2.00%) 
Subdural Hematoma *  1/50 (2.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lunasin Regimen
Affected / at Risk (%)
Total   45/50 (90.00%) 
Blood and lymphatic system disorders   
Hyponatremia *  1/50 (2.00%) 
Endocrine disorders   
Hyperglycemia *  1/50 (2.00%) 
Gastrointestinal disorders   
Constipation *  11/50 (22.00%) 
Fullness/early satiety *  8/50 (16.00%) 
Nausea *  3/50 (6.00%) 
Decreased Appetite *  2/50 (4.00%) 
Increased Appetite *  1/50 (2.00%) 
Bloating *  1/50 (2.00%) 
Diarrhea *  1/50 (2.00%) 
Flatulence *  1/50 (2.00%) 
Weight Gain *  1/50 (2.00%) 
Weight Loss *  1/50 (2.00%) 
Infections and infestations   
UTI *  1/50 (2.00%) 
Influenza Infection *  1/50 (2.00%) 
Musculoskeletal and connective tissue disorders   
Hand and Finger Swelling *  1/50 (2.00%) 
Irritated Hiatal Hernia *  1/50 (2.00%) 
Breast Tenderness *  1/50 (2.00%) 
Ear Ache *  1/50 (2.00%) 
Nervous system disorders   
Increased ALS progression *  2/50 (4.00%) 
Fall *  1/50 (2.00%) 
Confusion *  1/50 (2.00%) 
Restless Arm Movements *  1/50 (2.00%) 
Increased Fasciculations *  1/50 (2.00%) 
Increased Cramps *  1/50 (2.00%) 
Increased Pseudobulbar Affect *  1/50 (2.00%) 
Heaviness *  1/50 (2.00%) 
Psychiatric disorders   
Worsened Anxiety *  1/50 (2.00%) 
Renal and urinary disorders   
Prostate Enlargement *  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea *  2/50 (4.00%) 
Carbon Dioxide Retention *  1/50 (2.00%) 
Skin and subcutaneous tissue disorders   
Itching *  2/50 (4.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Richard Bedlack, MD, PhD
Organization: Duke University
Phone: 919-668-2839
Responsible Party: Richard Bedlack, M.D., Ph.D., Duke University
ClinicalTrials.gov Identifier: NCT02709330     History of Changes
Other Study ID Numbers: Pro00063754
First Submitted: March 5, 2016
First Posted: March 16, 2016
Results First Submitted: July 25, 2018
Results First Posted: December 13, 2018
Last Update Posted: December 13, 2018