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.

For each enrolled participant, matched historical controls will be identified from the PatientsLikeMe database. Participants will be matched according to their ALSFRS-R progression rate before they start on the Lunasin regimen (estimated by assuming their score was normal at 48 on the date of symptom onset).

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

Lunasin Regimen

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

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.

Change in Revised ALS Functional Rating Scale (ALSFRS-R)

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.

Individuals with ALS who are not on Lunasin.

ALS Controls

Healthy individuals who are not on Lunasin.

Healthy Controls

Change in H3 Histone Acetylation

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.

Percent Agreement Between the Weights Obtained by Patients and Study Coordinator

Rate of enrollment in reaching the 50 participants required to fill the trial.

Enrollment Rate

Percentage of surviving participants who completed the month 12 visit.

Retention Rate

The percentage of enrolled participants experiencing an ALSFRS-R improvement of at least 4 points lasting at least 12 months.

Frequency of ALS Reversals

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.

ALSFRS-R Accuracy

Subjects were consented specifically as controls for outcome measure 2 and not included in the treatment (Lunasin regimen) group.

Control

Overall Study

Richard Bedlack, MD, PhD

ALS (Amyotrophic Lateral Sclerosis)

LunaRich X Capsules, Reliv Now, ProVantage

Matched historical controls will be identified from the PatientsLikeMe database.

Historical control

Duke Medicine / Neurology

ALS Reversals - Lunasin Regimen

An Open-label, Single-center, 12-month Trial of a Lunasin Regimen for Patients With Amyotrophic Lateral Sclerosis (ALS)

Participants will be assigned a global unique ID number (GUID), which will allow de-identified data sharing.

Richard Bedlack, M.D., Ph.D.

Associate Professor of Neurology

Control group: systematic advice on swallowing, plus:
If no weight loss compared to usual weight: no intervention
if weight loss <5%: advice on a fat- and protein-enriched diet
if weight loss ≥5%: advice on a fat- and protein-enriched diet + 1 unit of ONS/day per os

Experimental "ONS" Group: systematic advice on swallowing + systematic advice on a fat- and protein-enriched diet, plus:
if no weight loss compared to usual weight: 1 ONS/day per os
if weight loss <5% compared to usual weight: 2 ONS/day per os
if weight loss ≥5% compared to usual weight: 3 ONS/day per os

Amyotrophic Lateral Sclerosis (ALS)

Oral nutritional supplementation

Service de Neurologie

Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients

Impact on Functional Status of Early Oral Nutritional Supplementation (ONS) in Amyotrophic Lateral Sclerosis (ALS) Patients

Change in the ALSFRS-R slope between T0 and T0+6 months (ALSFRS-R will be assessed by an examiner blinded to the intervention group).

Combined assessment of Function and Survival (CAFS)

Nutritional status will be evaluated by means of Body Mass Index and of Fat Mass.
Measurement will be performed at T0, T0+3 months and T0+6 months:

motor neuron disease/triglyceride

ALS Reversals - Lunasin Regimen

Oral Nutritional Supplementation in Amyotrophic Lateral Sclerosis (ALS) Patients

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