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Dietary Supplement for Elevated S-adenosylhomocysteine (SAH) (SAH Trial)
N/A
Waitlist Available
Led By Bassem F. El-Khodor, PhD
Research Sponsored by Standard Process Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial is testing a dietary supplement containing alpha-GPC, creatine, and ashwagandha. It targets individuals with high levels of a harmful substance called SAH in their blood. The supplement aims to lower these SAH levels to improve overall health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To determine the effect of the TP compared to placebo on plasma S-adenosylhomocysteine (SAH) concentration.
To determine the effect of the Test Product (TP) compared to placebo on plasma S-adenosylmethionine (SAM) concentration.
Secondary study objectives
To determine the effect of the TP compared to placebo on anger-hostility.
To determine the effect of the TP compared to placebo on confusion-bewilderment.
To determine the effect of the TP compared to placebo on depression-dejection.
+13 moreOther study objectives
Blood pressure
Body mass index
Body weight
+35 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Alpha-GPC, Creatine and Ashwagandha (Sensoril®)Experimental Treatment1 Intervention
Two servings (12 capsules) of study products will be taken twice per day with meals, one serving in the morning and one serving the afternoon/evening. One serving consists of 6 capsules. The time difference between the two servings must be at least 6 hours.
One serving:
* One capsule of Alpha GPC supplement
* Four capsules of Creatine monohydrate supplement
* One capsule of Sensoril (ashwagandha) supplement
Group II: PlaceboPlacebo Group1 Intervention
Participants will consume one serving (6 capsules), twice per day, with meals at least 6 hours apart.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpha-GPC, Creatine and Ashwagandha (Sensoril®)
2022
N/A
~40
Find a Location
Who is running the clinical trial?
Standard Process Inc.Lead Sponsor
12 Previous Clinical Trials
558 Total Patients Enrolled
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
36 Previous Clinical Trials
2,062 Total Patients Enrolled
Bassem F. El-Khodor, PhDPrincipal InvestigatorNutrition Innovation Center, Standard Process Inc.
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Alpha-GPC, Creatine and Ashwagandha (Sensoril®)