Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02082418
Recruitment Status : Unknown
Verified April 2019 by Marielle PKJ Engelen, PhD, Texas A&M University.
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2014
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Marielle PKJ Engelen, PhD, Texas A&M University

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 10, 2014
Last Update Posted Date April 11, 2019
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Alpha-lactalbumin Intake on Metabolic and Cognitive Functions in Elderly
Official Title  ICMJE Effects of Alpha-lactalbumin on Metabolic and Cognitive Functions in Healthy Older Adults
Brief 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Healthy
    healthy control subjects
    Interventions:
    • Dietary Supplement: Alpha-lactalbumin
    • Dietary Supplement: Whey
    • Dietary Supplement: Casein
  • Experimental: MCI
    mild cognitive impariments
    Interventions:
    • Dietary Supplement: Alpha-lactalbumin
    • Dietary Supplement: Whey
    • Dietary Supplement: Casein
  • Experimental: Dementia
    established diagnosis of dementia
    Interventions:
    • Dietary Supplement: Alpha-lactalbumin
    • Dietary Supplement: Whey
    • Dietary Supplement: Casein
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: March 7, 2018)
59
Original Estimated Enrollment  ICMJE
 (submitted: March 7, 2014)
40
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02082418
Other Study ID Numbers  ICMJE 2014-0065
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marielle PKJ Engelen, PhD, Texas A&M University
Study Sponsor  ICMJE Texas A&M University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marielle P Engelen, PhD Texas A&M University
PRS Account Texas A&M University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP