NCT07643675

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Glycine; Older Adults; Cognitive Decline; Brain-Derived Neutrophic Factor (BDNF); Cognitive Ag-ing; Inflammation.

Outcome Measures

Primary Outcomes (1)

  • Brain-Derived Neurotrophic Factor (BDNF) levels

    Evaluated the effects of glycine supplementation on cognitive performance, as meas-ured by the MMSE and MoCA scales, and its correlation with serum Brain-Derived Neurotrophic Factor (BDNF) levels in older adults.

    Baseline (T0), 3 months (T3) and 6 months (T6)

Study Arms (1)

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.

Dietary Supplement: Glycine

Interventions

GlycineDIETARY_SUPPLEMENT

Oral supplementation of glycine at a dose of 1,000 mg per day, administered daily over a 6-month period.

Glycine group

Eligibility Criteria

Age60 Years - 80 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals across all nutritional statuses according to Body Mass Index (BMI), under-weight, normal weight, overweight, and obesity

You may not qualify if:

  • 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 and mental incapacity, lack of willingness, or language barriers that prevent adequate understanding or co-operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escuela Superior de Medicina

México, State of Mexico, 01710, Mexico

Location

MeSH Terms

Conditions

Metabolic SyndromeCognitive DysfunctionInflammation

Interventions

Glycine

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesCognition DisordersNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Brenda Sarahí BS Beristain Lujano, MSc

    Escuela Superior de Medicina IPN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator and Doctoral Researcher

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start

December 1, 2024

Primary Completion

June 1, 2025

Study Completion

December 1, 2025

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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).

Locations