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

NCT05994794 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-07

No results posted yet for this study

Summary

S-adenosylhomocysteine (SAH) is the end-product of methylation reactions in the body and the precursor to homocysteine. Elevated SAH in the blood is a reflection of the dysregulation of what is known as the S-adenosylmethionine (SAM) cycle and has been associated with poor health outcomes. The SAM cycle is a series of reversible reactions necessary for the regulation of many processes in the body.

The goal of this clinical trial is to assess the ability of a dietary supplement to support healthy plasma SAH levels in individuals with high plasma SAH.

Participants in the study will attend a total of 4 clinic visits and consume study product daily for 12 weeks.

Conditions

  • Elevated S-adenosylhomocysteine

Interventions

DIETARY_SUPPLEMENT

Alpha-GPC, Creatine and Ashwagandha (Sensoril®)

Other Ingredients: Microcrystalline Cellulose, Rice Fiber, Maltodextrin, Silica, Vegetable Stearate

OTHER

Placebo

Microcrystalline Cellulose

Sponsors & Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    collaborator NETWORK

  • Standard Process Inc.

    lead INDUSTRY

Principal Investigators

  • Bassem F. El-Khodor, PhD · Nutrition Innovation Center, Standard Process Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-09
Primary Completion
2023-10-05
Completion
2023-10-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05994794 on ClinicalTrials.gov