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Protein Supplement

MCI for Mild Cognitive Impairment

N/A
Waitlist Available
Led By Marielle P Engelen, PhD
Research Sponsored by Texas A&M University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
Awards & highlights
No Placebo-Only Group

Summary

Aging modifies the metabolic pathway of the neurotransmitter serotonin by reducing the synthesis rate and increasing the breakdown rate of serotonin, possibly related to the observed enhanced sensitivity of the serotonergic pathway. Since serotonin plays a prominent role in neuropsychological functions such as anxiety, mood and memory, the enhanced sensitivity of the serotonergic pathway in aging can probably explain the fact that elderly are more vulnerable to develop cognitive deficits and depressive symptoms. Serotonin synthesis in brain is regulated by its precursor tryptophan (TRP). Because tryptophan is an essential amino acid, modifying the availability of tryptophan through dietary intake, can directly influence central serotonin metabolism and consequently affective and cognitive processes. The aim of this study is to test the hypothesis that an acute intake of whey protein with high levels of TRP such as alpha-lactalbumin can stabilize the metabolism of serotonin and subsequently enhance metabolic and cognitive functions in healthy older adults. The acute effects of this dietary protein will be investigated in subjects with mild cognitive impairment (MCI), or dementia, compared to control subjects in order to examine whether healthy older subject with MCI benefit more from the intake of alpha-lactalbumin and/or whey. The investigators will investigate if this meal can optimize serotonin metabolism by elevating plasma TRP levels and plasma TRP appearance and enhance splanchnic TRP extraction. In addition, the effects on mood and cognitive functions will be examined.

Eligible Conditions
  • Mild Cognitive Impairment

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Net whole-body protein synthesis
Secondary study objectives
Arginine turnover rate
Citrulline rate of appearance
Cognitive function and mood
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: MCIExperimental Treatment3 Interventions
mild cognitive impariments
Group II: HealthyExperimental Treatment3 Interventions
healthy control subjects
Group III: DementiaExperimental Treatment3 Interventions
established diagnosis of dementia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Whey
2019
N/A
~380
Casein
2014
Completed Phase 2
~330
Alpha-lactalbumin
2023
N/A
~30

Find a Location

Who is running the clinical trial?

Texas A&M UniversityLead Sponsor
147 Previous Clinical Trials
23,804 Total Patients Enrolled
Marielle P Engelen, PhDPrincipal InvestigatorTexas A&M University
2 Previous Clinical Trials
86 Total Patients Enrolled
~5 spots leftby Nov 2025