CompletedNot Applicable

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

United States40 participantsStarted 2022-12-09

Plain-language 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.

Who can participate

Age range

30 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy adults who are 30 to 75 years of age (inclusive).
. Have a BMI between 18.5 to 34.9 kg/m\^2 (inclusive).
. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product.
. Have elevated plasma SAH levels of ≥ 20 nmol/L and normal plasma homocysteine levels of ≤ 13 µmol/L at the screening visit (Visit 1).
. Individuals with childbearing potential must agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
. use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), or hormone implant (e.g., Norplant System), or intrauterine devices (e.g., Mirena); or

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine the effect of the Test Product (TP) compared to placebo on plasma S-adenosylmethionine (SAM) concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma S-adenosylhomocysteine (SAH) concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma homocysteine concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma cystathionine concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma cysteine concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma methionine concentration.

Timeframe: 12 weeks

Trial details

NCT IDNCT05994794

SponsorStandard Process Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-05

View on ClinicalTrials.gov More Elevated S-adenosylhomocysteine trials

Plain-language summary

Who can participate

Age range

30 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy adults who are 30 to 75 years of age (inclusive).
. Have a BMI between 18.5 to 34.9 kg/m\^2 (inclusive).
. In good general health (no uncontrolled diseases or conditions) as deemed by the investigator and is able to consume the study product.
. Have elevated plasma SAH levels of ≥ 20 nmol/L and normal plasma homocysteine levels of ≤ 13 µmol/L at the screening visit (Visit 1).
. Individuals with childbearing potential must agree to practice an acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
. use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), or hormone implant (e.g., Norplant System), or intrauterine devices (e.g., Mirena); or

What they're measuring

To determine the effect of the Test Product (TP) compared to placebo on plasma S-adenosylmethionine (SAM) concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma S-adenosylhomocysteine (SAH) concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma homocysteine concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma cystathionine concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma cysteine concentration.

Timeframe: 12 weeks

To determine the effect of the TP compared to placebo on plasma methionine concentration.

Timeframe: 12 weeks

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria