Last updated: 11/03/2018 23:10:37

Adapt and Perform: the Impact of Increased Dietary Protein on the Metabolic Adaptation to Endurance Running and Subsequent Endurance Performance

GSK study ID
205194
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Adapt and Perform: the Impact of Increased Dietary Protein on the Metabolic Adaptation to Endurance Running and Subsequent Endurance Performance
Trial description: This will be a single centre, examiner blind, two treatment, parallel group, (by site, baseline number of bleeding sites and smoking status), randomized study to assess the impact of a high protein diet on metabolic adaptation to endurance running and subsequent exercise performance.
Primary purpose:
Not applicable
Trial design:
Parallel Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Muscle transcriptional markers in the mitochondrial biogenesis pathway: Peroxisome proliferator-activated receptor gamma coactivator-1 alpha (PGC1α), silent information regulator T1 (SIRT1), peroxisome proliferator-activated receptor (PPAR)

Timeframe: Baseline upto Day 20

Secondary outcomes:

Exercise substrate utilisation

Timeframe: Baseline upto Day 20

Endurance performance

Timeframe: Baseline upto Day 20

Interventions:
  • Dietary: High Protein Diet
  • Dietary: High Carbohydrate Diet
    • Enrollment:
    20
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sports Nutritional Sciences
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    January 2016 to March 2016
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    18 - 40 Year
    Accepts healthy volunteers
    yes
    • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
    • Male participants aged between 18 and 40 years inclusive.
    • Use of concomitant medication known to be over the counter (OTC) analgesics (24 hours prior to first assessment visit).
    • Known or suspected intolerance or hypersensitivity to the study materials or any of -their stated ingredients.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
    • Male participants aged between 18 and 40 years inclusive.
    • Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history.
    • Participant has run a 10 km race in ≤ 38 minutes or a 5 km ≤ 18 minutes in the last 48 months and is currently training ≤ 4 times per week.
    Exclusion criteria:
    • Use of concomitant medication known to be over the counter (OTC) analgesics (24 hours prior to first assessment visit).
    • Known or suspected intolerance or hypersensitivity to the study materials or any of -their stated ingredients.
    • Has a history of or current evidence (within last 5 years) of abuse of alcohol or other substance, smoker.
    • Vegetarian/vegan or follows any other diet regime excludes certain food groups.
    • Consuming nutritional supplements in the 48 hours pre trial.
    • Current (within 14 days of the start of the study) or regular use of any prescription, OTC, herbal medicine unless the medication has been approved by the study physician. Vitamin supplements and occasional doses of OTC paracetamol for pain relief are permitted.
    • Current or in the 30 days prior to dosing use of any drug known to induce or inhibit hepatic drug metabolism (e.g. barbiturates, theophylline, cimetidine, or erythromycin).
    • Has an allergy to eggs (or any contents of the standardized breakfast).
    • Participant is lactose intolerant.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2016-23-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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