Elevated S-adenosylhomocysteineSAHNCT05994794
Role of a Dietary Supplement in Lowering SAH in Healthy Adults With Elevated Plasma SAH and Normal Homocysteine Levels
A study testing Alpha-GPC, Creatine and Ashwagandha (Sensoril®) in people with Elevated S-adenosylhomocysteine, run by Standard Process Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated S-adenosylhomocysteine
- What is being tested?
- Alpha-GPC, Creatine and Ashwagandha (Sensoril®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2022to 5 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- use for at least 1 month prior to the first dose of study product: double-barrier method, non-hormonal intrauterine devices (i.e., copper), or complete abstinence from sexual intercourse that may result in pregnancy; or
- vasectomy of partner at least 6 months prior to the first dose of study product.
- Individuals with the potential to impregnate others must agree to use condoms or other acceptable methods to prevent pregnancy throughout the study. Complete abstinence from sexual intercourse that may result in pregnancy is also acceptable.
- Agree to comply with concomitant treatment restrictions, permitted time frames and/or conditions listed in Study Protocol (No. S01-21-01-T0023) Section 6.5 (Concomitant Treatments).
- Have maintained stable dietary habits (including supplement intake), exercise habits and lifestyle for the last 3 months prior to screening and agree to maintain dietary and exercise habits and lifestyle throughout the study.
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- Individuals who are lactating, pregnant or planning to become pregnant during the study as confirmed at the baseline visit (Visit 2).
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- Currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit.
- Currently has any post Covid-19 condition(s) as defined by World Health Organization (WHO) (i.e., individuals with a history of a probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
- Have a history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney dysfunction or disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes.
- Have a history of thyroid disease, major affective disorder, psychiatric disorder (e.g., bipolar disorder) that required hospitalization in the prior year, autoimmune diseases (e.g., multiple sclerosis, Parkinson's, systemic lupus erythematosus, rheumatoid arthritis, etc.), or immune disorder (i.e., HIV/AIDS).
Show all 12Show fewer
- Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g. dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea).
- Have an active malignant disease, except basal or squamous cell skin carcinoma or carcinoma in situ of the uterine cervix.
- Major surgery in 3 months prior to the screening visit (Visit 1) or planned major surgery during the course of the study.
- History of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program).
- Receipt or use of test product(s) in another research study within 28 days prior to baseline or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
- Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Valiance Clinical Research
South Gate, California, 90280
About this study
Official title: A Randomized, Single-Blind, Placebo-Controlled Trial for the Role of a Dietary Supplement in Lowering S-Adenosylhomocysteine (SAH) in Healthy Adults With Elevated Plasma SAH and Normal Homocysteine Levels and Identification of Participants With Elevated Plasma SAH in the General Population Using the MethylQ Score
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.
Read the detailed description
Methionine, a dietary amino acid commonly found in meats, is processed by the body and yields the by-product S-adenosylhomocysteine (SAH), which then undergoes condensation with ATP to produce S-adenosylmethionine (SAM). SAM is the main methyl donor in many of the reactions that occur in the cell. These methyl reactions are well-known epigenetic mechanisms involved in DNA gene expression. When SAM donates its methyl group in a reaction, it becomes SAH which participates in a reversible reaction with homocysteine. Homocysteine is then removed through re-methylation to methionine using folate and vitamin B12. This decrease in homocysteine levels prevents the over-production of SAH, which can disrupt the methyl reactions throughout the body. Dysregulation of this pathway leads to elevated levels of SAH, which have been associated with various disease states. Therefore, an intervention which can lower SAH may ameliorate the outcomes associated with its elevation. This trial will evaluate the efficacy of a dietary supplement to lower SAH in individuals with elevated SAH and normal homocysteine. In addition, this study aims to explore the correlation between the MethylQ score (derived from 3 questionnaires) and measures of SAH level and the SAM:SAH ratio.
The test product contains alpha-GPC, creatine, and ashwagandha. Individually, these ingredients have been shown to improve levels of either SAH or homocysteine in clinical trials.
Participants will be assigned to either the test product or placebo at a 5:3 and consume study product orally for 12 weeks. Assessment measures will include methylation biomarkers, free cortisol index, mood states and MethylQ score in individuals with elevated SAH levels (≥ 20 nmol/L) and normal homocysteine (≤ 13 µmol/L).
The study will include a screening visit followed by a screening period lasting up to 90 days in duration with a remote check-in via phone call occurring between Day -40 and Day -30 (inclusive) for participants screened more than 30 days prior to the baseline visit on (Visit 2). Following the screening period, participants will attend a baseline visit on Day 1, an interim visit on Day 43 ± 3, and an end of study visit on the day after the 12-week (± 3 days) study product use (Day 85 ± 3). The study will include a total of 4 in-person visit days: a screening visit (Visit 1), a baseline visit (Visit 2), an interim visit (Visit 3), and an EOS visit (Visit 4).
- Conditions
- Elevated S-adenosylhomocysteine
- Being tested
- Alpha-GPC, Creatine and Ashwagandha (Sensoril®), Placebo
- Keywords
- Methylation, Alpha-GPC, Creatine, Ashwagandha
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-GPC, Creatine and Ashwagandha (Sensoril®)Dietary supplement
Other Ingredients: Microcrystalline Cellulose, Rice Fiber, Maltodextrin, Silica, Vegetable Stearate
PlaceboOther
Microcrystalline Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Alpha-GPC, Creatine and Ashwagandha (Sensoril®) | Experimental | 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 Receives: Dietary Supplement: Alpha-GPC, Creatine and Ashwagandha (Sensoril®) |
| Placebo | Placebo comparator | Participants will consume one serving (6 capsules), twice per day, with meals at least 6 hours apart. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of the Test Product (TP) compared to placebo on plasma S-adenosylmethionine (SAM) concentration.
Change from baseline in plasma SAM (nmol/L).
Measured: 12 weeks
To determine the effect of the TP compared to placebo on plasma S-adenosylhomocysteine (SAH) concentration.
Change from baseline in plasma SAH (nmol/L).
Measured: 12 weeks
To determine the effect of the TP compared to placebo on plasma homocysteine concentration.
Change from baseline in plasma homocysteine (umol/L).
Measured: 12 weeks
To determine the effect of the TP compared to placebo on plasma cystathionine concentration.
Change from baseline in plasma cystathionine (umol/dL).
Measured: 12 weeks
To determine the effect of the TP compared to placebo on plasma cysteine concentration.
Change from baseline in plasma cysteine (umol/dL).
Measured: 12 weeks
To determine the effect of the TP compared to placebo on plasma methionine concentration.
Change from baseline in plasma methionine (umol/dL).
Measured: 12 weeks
Secondary outcomes (16)
To determine the effect of the TP compared to placebo on plasma SAM concentration.
Change from baseline in plasma SAM (nmol/L).
Measured: 6 weeks
To determine the effect of the TP compared to placebo on plasma SAH concentration.
Change from baseline in plasma SAH (nmol/L).
Measured: 6 weeks
To determine the effect of the TP compared to placebo on plasma homocysteine concentration.
Change from baseline in plasma homocysteine (umol/L).
Measured: 6 weeks
To determine the effect of the TP compared to placebo on plasma cystathionine concentration.
Change from baseline in plasma cystathionine (umol/dL).
Measured: 6 weeks
To determine the effect of the TP compared to placebo on plasma methionine concentration.
Change from baseline in plasma methionine (umol/dL).
Measured: 6 weeks
To determine the effect of the TP compared to placebo on plasma cysteine concentration.
Change from baseline in plasma cysteine (umol/dL).
Measured: 6 weeks
To determine the effect of the TP compared to placebo on overall mood state.
Change from baseline in total mood disturbance assessed by Profile of Mood States (POMS) questionnaire. A higher score indicates a worse outcome.
Measured: 12 weeks
To determine the effect of the TP compared to placebo on anger-hostility.
Change from baseline in anger-hostility subscore from the POMS questionnaire. A higher score indicates a worse outcome.
Measured: 12 weeks
To determine the effect of the TP compared to placebo on vigor-activity.
Change from baseline in vigor-activity subscore from the POMS questionnaire. A higher score indicates a better outcome.
Measured: 12 weeks
To determine the effect of the TP compared to placebo on confusion-bewilderment.
Change from baseline in confusion-bewilderment subscore from the POMS questionnaire. A higher score indicates a worse outcome.
Measured: 12 weeks
To determine the effect of the TP compared to placebo on depression-dejection.
Change from baseline in depression-dejection subscore from the POMS questionnaire. A higher score indicates a worse outcome.
Measured: 12 weeks
To determine the effect of the TP compared to placebo on tension-anxiety.
Change from baseline in tension-anxiety subscore from the POMS questionnaire. A higher score indicates a worse outcome.
Measured: 12 weeks
To determine the effect of the TP compared to placebo on friendliness.
Change from baseline in friendliness subscore from the POMS questionnaire. A higher score indicates a better outcome.
Measured: 12 weeks
To determine the effect of the TP compared to placebo on fatigue-inertia.
Change from baseline in fatigue-interia subscore from the POMS questionnaire. A higher score indicates a worse outcome.
Measured: 12 weeks
To determine the effect of the TP compared to placebo on free cortisol index.
Change from baseline in the ratio of total cortisol/cortisol-binding globulin (CBG).
Measured: 12 weeks
To determine the effect of the TP compared to placebo on the MethylQ score.
Change from baseline in MethylQ score. A score greater than 30 indicates a worse outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start9 Dec 2022
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Elevated S-adenosylhomocysteineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Standard Process Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Bassem F. El-Khodor, PhD, Principal investigator, Nutrition Innovation Center, Standard Process Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994794
- Sponsor's protocol ID
- S01-21-01-T0023
- Acronym
- SAH
- Status last verified
- Mar 2024
- First submitted
- 28 Jun 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kennedy BP, Bottiglieri T, Arning E, Ziegler MG, Hansen LA, Masliah E. Elevated S-adenosylhomocysteine in Alzheimer brain: influence on methyltransferases and cognitive function. J Neural Transm (Vienna). 2004 Apr;111(4):547-67. doi: 10.1007/s00702-003-0096-5. Epub 2004 Feb 4.
PubMed 15057524Xiao Y, Huang W, Zhang J, Peng C, Xia M, Ling W. Increased plasma S-adenosylhomocysteine-accelerated atherosclerosis is associated with epigenetic regulation of endoplasmic reticulum stress in apoE-/- mice. Arterioscler Thromb Vasc Biol. 2015 Jan;35(1):60-70. doi: 10.1161/ATVBAHA.114.303817. Epub 2014 Oct 30.
PubMed 25359864Lawson BR, Eleftheriadis T, Tardif V, Gonzalez-Quintial R, Baccala R, Kono DH, Theofilopoulos AN. Transmethylation in immunity and autoimmunity. Clin Immunol. 2012 Apr;143(1):8-21. doi: 10.1016/j.clim.2011.10.007. Epub 2011 Dec 24.
PubMed 22364920Ganguly P, Alam SF. Role of homocysteine in the development of cardiovascular disease. Nutr J. 2015 Jan 10;14:6. doi: 10.1186/1475-2891-14-6.
PubMed 25577237Moore LD, Le T, Fan G. DNA methylation and its basic function. Neuropsychopharmacology. 2013 Jan;38(1):23-38. doi: 10.1038/npp.2012.112. Epub 2012 Jul 11.
PubMed 22781841Troen AM, Lutgens E, Smith DE, Rosenberg IH, Selhub J. The atherogenic effect of excess methionine intake. Proc Natl Acad Sci U S A. 2003 Dec 9;100(25):15089-94. doi: 10.1073/pnas.2436385100. Epub 2003 Dec 1.
PubMed 14657334Olthof MR, Brink EJ, Katan MB, Verhoef P. Choline supplemented as phosphatidylcholine decreases fasting and postmethionine-loading plasma homocysteine concentrations in healthy men. Am J Clin Nutr. 2005 Jul;82(1):111-7. doi: 10.1093/ajcn.82.1.111.
PubMed 16002808Innis SM, Davidson AG, Melynk S, James SJ. Choline-related supplements improve abnormal plasma methionine-homocysteine metabolites and glutathione status in children with cystic fibrosis. Am J Clin Nutr. 2007 Mar;85(3):702-8. doi: 10.1093/ajcn/85.3.702.
PubMed 17344490Korzun WJ. Oral creatine supplements lower plasma homocysteine concentrations in humans. Clin Lab Sci. 2004 Spring;17(2):102-6.
PubMed 15168891Bonilla DA, Moreno Y, Gho C, Petro JL, Odriozola-Martinez A, Kreider RB. Effects of Ashwagandha (Withania somnifera) on Physical Performance: Systematic Review and Bayesian Meta-Analysis. J Funct Morphol Kinesiol. 2021 Feb 11;6(1):20. doi: 10.3390/jfmk6010020.
PubMed 33670194Pohl F, Dominique A, Dufour J, Wang J, Lin XL, Sharif B, Wilson M, Gonzalez L, El-Khodor BF. Lowering plasma S-Adenosylhomocysteine (SAH) in healthy adults with elevated SAH and normal homocysteine using nutritional supplementation. Nutr Metab Cardiovasc Dis. 2025 Dec;35(12):104221. doi: 10.1016/j.numecd.2025.104221. Epub 2025 Jul 5.
PubMed 40883125
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Placebo-Controlled Trial for the Role of a Dietary Supplement in Lowering S-Adenosylhomocysteine (SAH) in Healthy Adults With Elevated Plasma SAH and Normal Homocysteine Levels and Identification of Participants With Elevated Plasma SAH in the General Population Using the MethylQ Score
- ClinicalTrials.gov ID
- NCT05994794
- Acronym / sponsor ID
- SAH / S01-21-01-T0023
- Conditions
- Elevated S-adenosylhomocysteine
- Keywords
- Methylation, Alpha-GPC, Creatine, Ashwagandha
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Standard Process Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methionine, a dietary amino acid commonly found in meats, is processed by the body and yields the by-product S-adenosylhomocysteine (SAH), which then undergoes condensation with ATP to produce S-adenosylmethionine (SAM). SAM is the main methyl donor in many of the reactions that occur in the cell. These methyl reactions are well-known epigenetic mechanisms involved in DNA gene expression. When SAM donates its methyl group in a reaction, it becomes SAH which participates in a reversible reaction with homocysteine. Homocysteine is then removed through re-methylation to methionine using folate and vitamin B12. This decrease in homocysteine levels prevents the over-production of SAH, which can disrupt the methyl reactions throughout the body. Dysregulation of this pathway leads to elevated levels of SAH, which have been associated with various disease states. Therefore, an intervention which can lower SAH may ameliorate the outcomes associated with its elevation. This trial will evaluate the efficacy of a dietary supplement to lower SAH in individuals with elevated SAH and normal homocysteine. In addition, this study aims to explore the correlation between the MethylQ score (derived from 3 questionnaires) and measures of SAH level and the SAM:SAH ratio.
The test product contains alpha-GPC, creatine, and ashwagandha. Individually, these ingredients have been shown to improve levels of either SAH or homocysteine in clinical trials.
Participants will be assigned to either the test product or placebo at a 5:3 and consume study product orally for 12 weeks. Assessment measures will include methylation biomarkers, free cortisol index, mood states and MethylQ score in individuals with elevated SAH levels (≥ 20 nmol/L) and normal homocysteine (≤ 13 µmol/L).
The study will include a screening visit followed by a screening period lasting up to 90 days in duration with a remote check-in via phone call occurring between Day -40 and Day -30 (inclusive) for participants screened more than 30 days prior to the baseline visit on (Visit 2). Following the screening period, participants will attend a baseline visit on Day 1, an interim visit on Day 43 ± 3, and an end of study visit on the day after the 12-week (± 3 days) study product use (Day 85 ± 3). The study will include a total of 4 in-person visit days: a screening visit (Visit 1), a baseline visit (Visit 2), an interim visit (Visit 3), and an EOS visit (Visit 4).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-GPC, Creatine and Ashwagandha (Sensoril®) | Experimental | Dietary Supplement: Alpha-GPC, Creatine and Ashwagandha (Sensoril®)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 |
| Placebo | Placebo comparator | Other: PlaceboParticipants will consume one serving (6 capsules), twice per day, with meals at least 6 hours apart. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (12 listed)
- Individuals who are lactating, pregnant or planning to become pregnant during the study as confirmed at the baseline visit (Visit 2).
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- Currently has COVID-19 or tests positive for COVID-19 within 28 days prior to baseline visit.
- Currently has any post Covid-19 condition(s) as defined by World Health Organization (WHO) (i.e., individuals with a history of a probable or confirmed SARS-CoV-2 infection, usually three months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis).
- Have a history of heart disease/cardiovascular disease, uncontrolled hypertension (140/90 or greater mmHg), kidney dysfunction or disease (dialysis or renal failure), hepatic impairment or disease, or Type I or Type II diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-GPC, Creatine and Ashwagandha (Sensoril®)Other Ingredients: Microcrystalline Cellulose, Rice Fiber, Maltodextrin, Silica, Vegetable Stearate | Dietary supplement | Alpha-GPC, Creatine and Ashwagandha (Sensoril®) |
| PlaceboMicrocrystalline Cellulose | Other | Placebo |
Primary outcome
To determine the effect of the Test Product (TP) compared to placebo on plasma S-adenosylmethionine (SAM) concentration.
Time frame: 12 weeks
Change from baseline in plasma SAM (nmol/L).
To determine the effect of the TP compared to placebo on plasma S-adenosylhomocysteine (SAH) concentration.
Time frame: 12 weeks
Change from baseline in plasma SAH (nmol/L).
To determine the effect of the TP compared to placebo on plasma homocysteine concentration.
Time frame: 12 weeks
Change from baseline in plasma homocysteine (umol/L).
To determine the effect of the TP compared to placebo on plasma cystathionine concentration.
Time frame: 12 weeks
Change from baseline in plasma cystathionine (umol/dL).
To determine the effect of the TP compared to placebo on plasma cysteine concentration.
Time frame: 12 weeks
Change from baseline in plasma cysteine (umol/dL).
To determine the effect of the TP compared to placebo on plasma methionine concentration.
Time frame: 12 weeks
Change from baseline in plasma methionine (umol/dL).
16 secondary outcomes
To determine the effect of the TP compared to placebo on plasma SAM concentration.
Time frame: 6 weeks
To determine the effect of the TP compared to placebo on plasma SAH concentration.
Time frame: 6 weeks
To determine the effect of the TP compared to placebo on plasma homocysteine concentration.
Time frame: 6 weeks
To determine the effect of the TP compared to placebo on plasma cystathionine concentration.
Time frame: 6 weeks
To determine the effect of the TP compared to placebo on plasma methionine concentration.
Time frame: 6 weeks
To determine the effect of the TP compared to placebo on plasma cysteine concentration.
Time frame: 6 weeks
To determine the effect of the TP compared to placebo on overall mood state.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on anger-hostility.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on vigor-activity.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on confusion-bewilderment.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on depression-dejection.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on tension-anxiety.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on friendliness.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on fatigue-inertia.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on free cortisol index.
Time frame: 12 weeks
To determine the effect of the TP compared to placebo on the MethylQ score.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 15057524Kennedy BP, Bottiglieri T, Arning E, Ziegler MG, Hansen LA, Masliah E. Elevated S-adenosylhomocysteine in Alzheimer brain: influence on methyltransferases and cognitive function. J Neural Transm (Vienna). 2004 Apr;111(4):547-67. doi: 10.1007/s00702-003-0096-5. Epub 2004 Feb 4.
- Background: PubMed 25359864Xiao Y, Huang W, Zhang J, Peng C, Xia M, Ling W. Increased plasma S-adenosylhomocysteine-accelerated atherosclerosis is associated with epigenetic regulation of endoplasmic reticulum stress in apoE-/- mice. Arterioscler Thromb Vasc Biol. 2015 Jan;35(1):60-70. doi: 10.1161/ATVBAHA.114.303817. Epub 2014 Oct 30.
- Background: PubMed 22364920Lawson BR, Eleftheriadis T, Tardif V, Gonzalez-Quintial R, Baccala R, Kono DH, Theofilopoulos AN. Transmethylation in immunity and autoimmunity. Clin Immunol. 2012 Apr;143(1):8-21. doi: 10.1016/j.clim.2011.10.007. Epub 2011 Dec 24.
- Background: PubMed 25577237Ganguly P, Alam SF. Role of homocysteine in the development of cardiovascular disease. Nutr J. 2015 Jan 10;14:6. doi: 10.1186/1475-2891-14-6.
- Background: PubMed 22781841Moore LD, Le T, Fan G. DNA methylation and its basic function. Neuropsychopharmacology. 2013 Jan;38(1):23-38. doi: 10.1038/npp.2012.112. Epub 2012 Jul 11.
- Background: PubMed 14657334Troen AM, Lutgens E, Smith DE, Rosenberg IH, Selhub J. The atherogenic effect of excess methionine intake. Proc Natl Acad Sci U S A. 2003 Dec 9;100(25):15089-94. doi: 10.1073/pnas.2436385100. Epub 2003 Dec 1.
- Background: PubMed 16002808Olthof MR, Brink EJ, Katan MB, Verhoef P. Choline supplemented as phosphatidylcholine decreases fasting and postmethionine-loading plasma homocysteine concentrations in healthy men. Am J Clin Nutr. 2005 Jul;82(1):111-7. doi: 10.1093/ajcn.82.1.111.
- Background: PubMed 17344490Innis SM, Davidson AG, Melynk S, James SJ. Choline-related supplements improve abnormal plasma methionine-homocysteine metabolites and glutathione status in children with cystic fibrosis. Am J Clin Nutr. 2007 Mar;85(3):702-8. doi: 10.1093/ajcn/85.3.702.
- Background: PubMed 15168891Korzun WJ. Oral creatine supplements lower plasma homocysteine concentrations in humans. Clin Lab Sci. 2004 Spring;17(2):102-6.
- Background: PubMed 33670194Bonilla DA, Moreno Y, Gho C, Petro JL, Odriozola-Martinez A, Kreider RB. Effects of Ashwagandha (Withania somnifera) on Physical Performance: Systematic Review and Bayesian Meta-Analysis. J Funct Morphol Kinesiol. 2021 Feb 11;6(1):20. doi: 10.3390/jfmk6010020.
- Derived from this study: PubMed 40883125Pohl F, Dominique A, Dufour J, Wang J, Lin XL, Sharif B, Wilson M, Gonzalez L, El-Khodor BF. Lowering plasma S-Adenosylhomocysteine (SAH) in healthy adults with elevated SAH and normal homocysteine using nutritional supplementation. Nutr Metab Cardiovasc Dis. 2025 Dec;35(12):104221. doi: 10.1016/j.numecd.2025.104221. Epub 2025 Jul 5.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassem F. El-Khodor, PhD principal investigator
Nutrition Innovation Center, Standard Process Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha-GPC, Creatine and Ashwagandha (Sensoril®) in people with Elevated S-adenosylhomocysteine, run by Standard Process Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of the Test Product (TP) compared to placebo on plasma S-adenosylmethionine (SAM) concentration. (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05994794, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.