Effects of Alpha-lactalbumin Intake on Metabolic and Cognitive Functions in Elderly

Completed · Not applicable

Conditions studied: Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT02082418

Run by

Texas A&M University

People needed

59

Starts

2014-04-02

Expected to finish

2016-12-01

Last updated by the study team

2025-09-30

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
• Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• Indication of severe cognitive impairment (MOCA score < 17)
• Established diagnosis of Insulin Dependent Diabetes Mellitus
• History of untreated metabolic disease(s) including hepatic or renal disorder
• Presence of acute illness or metabolically unstable chronic illness
• Presence of fever within the last 3 days
• Preplanned surgery of procedures that would interfere with the conduct of the study
• Any other condition according to the PI or study physician that would interfere with proper conduct of the study / safety of the patient
• Current alcohol or drug abuse
• Known allergy to milk or milk products
• Use of long-term oral corticosteroids or short course of oral corticosteroids 4 weeks preceding first test day
• Use of protein or amino acid containing nutritional supplements within 5 days of test day
• (Possible) pregnancy
• BMI of < 18.5 or ≥ 40 kg/m2
• Dietary or lifestyle characteristics: When during the period from enrollment to completion of the study (end of test day) any condition is developed, whether causing the subject to not meet inclusion criteria or to meet exclusion criteria, the subject will be excluded from the study

Where it is running

• Texas A&M University — College Station, Texas, United States

Full record on ClinicalTrials.gov

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