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NCT02082418 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Texas A&M University.

Completed
Registry status
NA
Development phase
59
Enrollment target

NCT02082418: Completed NA study, sponsored by Texas A&M University.

NCT02082418 is a NA study that has completed, run by Texas A&M University. The registered enrollment target is 59 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02082418, a NA study, has completed, sponsored by Texas A&M University.

COMPLETED
Registry status
NA
Development phase
59 participants
Enrollment target

Study 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.

Primary Outcome

Change in whole-body protein synthesis rate after intake of meal

Interventions

  • DIETARY_SUPPLEMENT Alpha-lactalbumin
  • DIETARY_SUPPLEMENT Whey
  • DIETARY_SUPPLEMENT Casein

Trial Details

FieldValue
Enrollment Target 59 participants
Start Date 2014-04-02
Est. Completion 2016-12-01
Phase NA
Texas A&M University

95 total trials

What the finished NCT02082418 record still lists

NCT02082418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 3 interventions - of which Alpha-lactalbumin is the first listed.

NCT02082418 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02082418 about?

NCT02082418 is a clinical study titled "Effects of Alpha-lactalbumin Intake on Metabolic and Cognitive Functions in Elderly". 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 functi...

What is the current status of trial NCT02082418?

This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2014-04-02. Estimated completion is 2016-12-01.

What interventions are being tested in trial NCT02082418?

The interventions under investigation include: Alpha-lactalbumin (DIETARY_SUPPLEMENT), Whey (DIETARY_SUPPLEMENT), Casein (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02082418?

This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02082418's enrollment target sits among peer trials

59 1256th of 2000 higher than 745 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02082418, the US trial registry maintained by the National Library of Medicine. NCT02082418 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.