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

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

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 more

Other study objectives

Blood pressure

Body mass index

Body weight

+35 more

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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