- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07643675
Glycine Supplementation Improves Cognitive Performance in Mexican Older Adults (Glycine)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
State of Mexico
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México, State of Mexico, Mexico, 01710
- Escuela Superior de Medicina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals across all nutritional statuses according to Body Mass Index (BMI), under-weight, normal weight, overweight, and obesity
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glycine group
Participants received an oral daily dose of 1,000 mg of glycine for a duration of 6 months to evaluate metabolic and cognitive outcomes.
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Oral supplementation of glycine at a dose of 1,000 mg per day, administered daily over a 6-month period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain-Derived Neurotrophic Factor (BDNF) levels
Time Frame: Baseline (T0), 3 months (T3) and 6 months (T6)
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brenda Sarahí BS Beristain Lujano, MSc, Escuela Superior de Medicina IPN
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Metabolic Diseases
- Neurocognitive Disorders
- Glucose Metabolism Disorders
- Cognition Disorders
- Insulin Resistance
- Hyperinsulinism
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Cognitive Dysfunction
- Metabolic Syndrome
- Inflammation
- Amino Acids, Peptides, and Proteins
- Amino Acids
- Glycine
Other Study ID Numbers
- HGDFF/DIR/CEI/232/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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