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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

Awards & highlights

SAH Trial Summary

This trial will evaluate whether dietary supplement can help regulate a body process associated with poor health outcomes. Participants attend 4 visits and take product daily for 12 wks.

SAH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 more

Other outcome measures

Blood pressure

Body mass index

Body weight

+35 more

SAH Trial 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

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Who is running the clinical trial?

Standard Process Inc.Lead Sponsor

12 Previous Clinical Trials

566 Total Patients Enrolled

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK

32 Previous Clinical Trials

1,873 Total Patients Enrolled

Bassem F. El-Khodor, PhDPrincipal InvestigatorNutrition Innovation Center, Standard Process Inc.

Media Library

Dietary Supplement (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994794 — N/A

Elevated S-adenosylhomocysteine Research Study Groups: Placebo, Alpha-GPC, Creatine and Ashwagandha (Sensoril®)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research accept participants over the age of eighty?

"As per the stated requirements of this clinical trial, participants must be between 30 and 75 years old to qualify for inclusion."

Answered by AI

Are there vacant slots to participate in this clinical experiment?

"The research study is currently open for recruitment, as per the details on clinicaltrials.gov. This project was first advertised on December 9th 2022 and has been revised most recently on August 8th 2023."

Answered by AI

How many participants are actively being recruited for this research project?

"That is correct. The information hosted on clinicaltrials.gov shows that this study has been open to recruitment since December 9th 2022 and was recently updated in August 8th 2023, seeking 40 volunteers at a single medical centre."

Answered by AI

What criteria must a participant fulfill to be eligible for this clinical research?

"To participate in this study, individuals must possess raised levels of s-adenosylhomocysteine and be between the ages 30 to 75. This trial is looking for 40 participants."

Answered by AI

What outcomes is this experiment aiming to elucidate?

"This clinical trial, which will be conducted over a 3-month period, seeks to evaluate the effect of TP versus placebo on S-adenosylhomocysteine (SAH) plasma concentrations. Secondary objectives include assessing changes in cystathionine, cysteine and methionine levels relative to baseline measurements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Role of a Dietary Supplement in Lowering SAH in Healthy Adults With Elevated Plasma SAH and Normal Homocysteine Levels

2022. "Role of a Dietary Supplement in Lowering SAH in Healthy Adults With Elevated Plasma SAH and Normal Homocysteine Levels". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05994794.