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

This study is currently recruiting participants.
Verified April 2017 by Marielle PKJ Engelen, PhD, Texas A&M University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02082418
First Posted: March 10, 2014
Last Update Posted: April 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment Dietary Supplement: Alpha-lactalbumin Dietary Supplement: Whey Dietary Supplement: Casein

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Alpha-lactalbumin on Metabolic and Cognitive Functions in Healthy Older Adults

Resource links provided by NLM:


Further study details as provided by Marielle PKJ Engelen, PhD, Texas A&M University:

Primary Outcome Measures:
  • Net whole-body protein synthesis [ Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal ]
    Change in whole-body protein synthesis rate after intake of meal


Secondary Outcome Measures:
  • Citrulline rate of appearance [ Time Frame: Postabsorptive state during 2 hours ]
    Plasma enrichment of citrulline

  • Skeletal and respiratory muscle strength [ Time Frame: 1 day ]
    Difference in leg strength and fatigue, handgrip strength and fatigue, and inspiratory and expiratory pressure between older adults with and without MCI.

  • Cognitive function and mood [ Time Frame: Postabsorptive state during 3 hours and change after feeding ]
    Outcome of neuro-psychological tests in healthy older adults with and without MCI in relation to the tryptophan metabolism

  • Protein digestion after feeding [ Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal ]
    Ratio enrichment free phenylalanine versus phenylalanine from protein spirulina

  • Arginine turnover rate [ Time Frame: Postabsorptive state during 3 hours ]
    Arginine enrichment in plasma

  • Whole body collagen breakdown rate [ Time Frame: Postabsorptive state during 3 hours ]
    Hydroxyproline enrichment in plasma

  • Tryptophan turnover rate [ Time Frame: Postabsorptive state during 3 hours and change after feeding ]
    Tryptophan enrichment in plasma in postabsorptive state and after intake of meal

  • Insulin response to feeding [ Time Frame: During 3 hours after feeding ]
    Acute change from postabsorptive state after intake of meal

  • Fat-free mass [ Time Frame: Postabsorptive state during 15 min ]
    Characteristics of study subjects

  • Myofibrillar protein breakdown rate [ Time Frame: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal ]
    3methylhistidine enrichment in plasma

  • Glycine rate of appearance [ Time Frame: Postabsorptive state during 3 hours ]
    Glycine enrichment in plasma

  • Taurine turnover rate [ Time Frame: Postabsorptive state during 3 hours ]
    Enrichment of taurine in plasma


Estimated Enrollment: 40
Study Start Date: March 2014
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy
healthy control subjects
Dietary Supplement: Alpha-lactalbumin
Subjects will ingest the liquid meal containing alpha-lactalbumin and carbohydrates (0.6 g/kg FFM protein + 0.3 g/kg FFM carbohydrates).
Dietary Supplement: Whey
commercially available whey protein
Dietary Supplement: Casein
commercially available casein protein
Experimental: MCI
mild cognitive impariments
Dietary Supplement: Alpha-lactalbumin
Subjects will ingest the liquid meal containing alpha-lactalbumin and carbohydrates (0.6 g/kg FFM protein + 0.3 g/kg FFM carbohydrates).
Dietary Supplement: Whey
commercially available whey protein
Dietary Supplement: Casein
commercially available casein protein
Experimental: Dementia
established diagnosis of dementia
Dietary Supplement: Alpha-lactalbumin
Subjects will ingest the liquid meal containing alpha-lactalbumin and carbohydrates (0.6 g/kg FFM protein + 0.3 g/kg FFM carbohydrates).
Dietary Supplement: Whey
commercially available whey protein
Dietary Supplement: Casein
commercially available casein protein

Detailed Description:
The study involves for all subjects 3 test days (approximately 8 hours each). On this test day the investigators will examine the acute effects of a protein meal. Subjects will receive a mixture of alpha-lactalbumin and/or whey and/or casein, carbohydrates and amino acid stable isotopes to investigate protein and amino acid kinetics (assigned to alpha-lactalbumin or whey or casein group on test day 1, then switch on test day 2 and 3). The subjects will receive these stable isotopes by infusion in their blood and by oral intake (e.g. simultaneously with protein meal). For study purposes, blood will be drawn approx. 25 times during 8 hours on the test day, altogether about 100-120 ml of blood will be drawn on the test day.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria subjects with dementia:

  • Dementia diagnosis
  • Ability to walk, sit down and stand up independently
  • Age 55 years or older
  • Ability to lie in supine or elevated position for 8 hours
  • Willingness and ability to comply with the protocol, including:

Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit

Inclusion criteria healthy subjects:

  • Healthy male or female according to the investigator's or appointed staff's judgment
  • Ability to walk, sit down and stand up independently
  • Age 55 years or older
  • Ability to lie in supine or elevated position for 8 hours
  • Willingness and ability to comply with the protocol, including:

Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082418


Contacts
Contact: Marielle P Engelen, PhD 979-220-2282 mpkj.engelen@ctral.org
Contact: Cindy Lieben, PhD 979-324-5428 ck.lieben@ctral.org

Locations
United States, Texas
Texas A&M University Recruiting
College Station, Texas, United States, 77843
Contact: Marielle P Engelen, PhD    979-220-2282    mpkj.engelen@ctral.org   
Sponsors and Collaborators
Texas A&M University
Investigators
Principal Investigator: Marielle P Engelen, PhD Texas A&M University
  More Information

Responsible Party: Marielle PKJ Engelen, PhD, PhD, Texas A&M University
ClinicalTrials.gov Identifier: NCT02082418     History of Changes
Other Study ID Numbers: 2014-0065
First Submitted: March 6, 2014
First Posted: March 10, 2014
Last Update Posted: April 19, 2017
Last Verified: April 2017

Keywords provided by Marielle PKJ Engelen, PhD, Texas A&M University:
Mild cognitive impairment
Protein digestion
Tryptophan digestion
Cognitive function
Mood
Muscle function
Alpha-lactalbumin

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action