Older Adults With Cognitive DeclineGlycineNCT07643675
Glycine Supplementation Improves Cognitive Performance in Mexican Older Adults
A study testing Glycine in people with Older Adults With Cognitive Decline and Insulin Resistance Syndrome, run by Brenda Sarahí Beristain Lujano at 1 site in Mexico.
Trial summary
The purpose of this study was to evaluate the effects of daily glycine supplementation on metabolic health and cognitive performance in older adults. Over a period of six months, participants received 1,000 mg of glycine per day to determine if this amino acid could improve markers of insulin resistance, glucose… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults With Cognitive Decline, Insulin Resistance Syndrome, Aging
- What is being tested?
- Glycine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteMexico
- Study dates
- 1 Dec 2024to 1 Dec 2025
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -Individuals across all nutritional statuses according to Body Mass Index (BMI): underweight, normal weight, overweight, and obesity.
Who cannot join
- Clinically relevant comorbidities (requiring patient hospitalization or a diagnosis of any infectious/contagious disease).
- Consumption of polyphenol-based supplements or herbal blends within the two weeks prior to the study.
- Mental incapacity.
- Lack of willingness.
- Language barriers that prevent adequate understanding or co-operation.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to evaluate the effects of daily glycine supplementation on metabolic health and cognitive performance in older adults. Over a period of six months, participants received 1,000 mg of glycine per day to determine if this amino acid could improve markers of insulin resistance, glucose metabolism, and cognitive functions such as memory and executive tasks.
The research aimed to identify whether this nutritional intervention provides a safe and effective strategy to support healthy aging, focusing on the link between metabolic balance and brain health in the elderly population.
Read the detailed description
A 6-month longitudinal study was conducted, featuring a glycine supplementation phase followed by a dietary maintenance period. Cognitive assessments and serum BDNF levels were monitored at baseline, 3 months (T3), and 6 months (T6). Which included the evaluation of fasting glucose, insulin levels, insulin resistance indices, and specific metabolic biomarkers. Concurrently, cognitive functions were evaluated utilizing standardized neuropsychological instruments to measure changes in memory, attention, and executive function. Linear Mixed-Effects Models (LMM) were used to analyze temporal trajectories.
- Being tested
- Glycine
- Keywords
- Glycine, Older Adults, Cognitive Decline, Brain-Derived Neutrophic Factor (BDNF), Inflammation
- Medical subject headings
- Metabolic Syndrome, Cognitive Dysfunction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycineDietary supplement
Oral supplementation of glycine at a dose of 1,000 mg per day, administered daily over a 6-month period.
| Study group | Role | What they receive |
|---|---|---|
| Glycine group | Experimental | Participants received an oral daily dose of 1,000 mg of glycine for a duration of 6 months to evaluate metabolic and cognitive outcomes. Receives: Dietary Supplement: Glycine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain-Derived Neurotrophic Factor (BDNF) levels
Serum concentrations of Brain-Derived Neurotrophic Factor (BDNF) measured via ELISA. Unit of Measure: pg/mL
Measured: Baseline (T0), 3 months (T3) and 6 months (T6)
Secondary outcomes (1)
Cognitive performance evaluated by the Cognitive performance was assessed using the Montreal Cognitive Assessment (MoCA).
Cognitive performance assessed using the Cognitive performance was assessed using the Montreal Cognitive Assessment (MoCA). Total scores range from 0 to 30, where higher scores indicate better cognitive performance.
- ≥ 26 points: Considered within the normal range.
- 18 - 25 points: Commonly associated with Mild Cognitive Impairment (MCI).
- 10 - 17 points: Suggests Moderate Cognitive Impairment.
- < 10 points: Suggests Severe Cognitive Impairment.
Measured: Baseline (T0), 3 months (T3) and 6 months (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Dec 2024
- Primary completion1 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults With Cognitive DeclineStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group, open-label study designed to evaluate longitudinal changes in metabolic and cognitive parameters from baseline (T0) to 6 months (T6) following daily glycine supplementation.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brenda Sarahí Beristain Lujano
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, National Polytechnic Institute, Mexico
- Responsible party
- Sponsor-investigator, Brenda Sarahí Beristain Lujano, Escuela Superior de Medicina
- Investigators
- Brenda Sarahí BS Beristain Lujano, MSc, Principal investigator, Escuela Superior de Medicina IPN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643675
- Sponsor's protocol ID
- HGDFF/DIR/CEI/232/2024
- Acronym
- Glycine
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy and confidentiality of the participants, in accordance with the informed consent and the guidelines of the Institutional Review Board (IRB).
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycine Supplementation Improves Cognitive Performance in Mexican Older Adults
- ClinicalTrials.gov ID
- NCT07643675
- Acronym / sponsor ID
- Glycine / HGDFF/DIR/CEI/232/2024
- Keywords
- Glycine, Older Adults, Cognitive Decline, Brain-Derived Neutrophic Factor (BDNF), Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Brenda Sarahí Beristain LujanoUniversity, hospital or other
- Collaborators
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, National Polytechnic Institute, Mexico
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 11 Jun 2026 (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.
The purpose of this study was to evaluate the effects of daily glycine supplementation on metabolic health and cognitive performance in older adults. Over a period of six months, participants received 1,000 mg of glycine per day to determine if this amino acid could improve markers of insulin resistance, glucose metabolism, and cognitive functions such as memory and executive tasks.
The research aimed to identify whether this nutritional intervention provides a safe and effective strategy to support healthy aging, focusing on the link between metabolic balance and brain health in the elderly population.
Detailed description
A 6-month longitudinal study was conducted, featuring a glycine supplementation phase followed by a dietary maintenance period. Cognitive assessments and serum BDNF levels were monitored at baseline, 3 months (T3), and 6 months (T6). Which included the evaluation of fasting glucose, insulin levels, insulin resistance indices, and specific metabolic biomarkers. Concurrently, cognitive functions were evaluated utilizing standardized neuropsychological instruments to measure changes in memory, attention, and executive function. Linear Mixed-Effects Models (LMM) were used to analyze temporal trajectories.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group, open-label study designed to evaluate longitudinal changes in metabolic and cognitive parameters from baseline (T0) to 6 months (T6) following daily glycine supplementation.
| Arm | Type | Receives |
|---|---|---|
| Glycine group | Experimental | Dietary Supplement: GlycineParticipants received an oral daily dose of 1,000 mg of glycine for a duration of 6 months to evaluate metabolic and cognitive outcomes. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Individuals across all nutritional statuses according to Body Mass Index (BMI): underweight, normal weight, overweight, and obesity.
Key exclusion criteria (5 listed)
- Clinically relevant comorbidities (requiring patient hospitalization or a diagnosis of any infectious/contagious disease).
- Consumption of polyphenol-based supplements or herbal blends within the two weeks prior to the study.
- Mental incapacity.
- Lack of willingness.
- Language barriers that prevent adequate understanding or co-operation.
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 |
|---|---|---|
| GlycineOral supplementation of glycine at a dose of 1,000 mg per day, administered daily over a 6-month period. | Dietary supplement | Glycine group |
Primary outcome
Brain-Derived Neurotrophic Factor (BDNF) levels
Time frame: Baseline (T0), 3 months (T3) and 6 months (T6)
Serum concentrations of Brain-Derived Neurotrophic Factor (BDNF) measured via ELISA. Unit of Measure: pg/mL
1 secondary outcome
Cognitive performance evaluated by the Cognitive performance was assessed using the Montreal Cognitive Assessment (MoCA).
Time frame: Baseline (T0), 3 months (T3) and 6 months (T6)
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 15 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy and confidentiality of the participants, in accordance with the informed consent and the guidelines of the Institutional Review Board (IRB).
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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.
Brenda Sarahí BS Beristain Lujano, MSc principal investigator
Escuela Superior de Medicina IPN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glycine in people with Older Adults With Cognitive Decline and Insulin Resistance Syndrome, run by Brenda Sarahí Beristain Lujano at 1 site in Mexico.
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 1 inclusion and 5 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 15 Jun 2026. 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 Mexico. 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. 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?
Brain-Derived Neurotrophic Factor (BDNF) levels (time frame: Baseline (T0), 3 months (T3) and 6 months (T6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.