A Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy of Oleuropein on Skeletal Muscle Energy Metabolism and Fatigue in Humans
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Société des Produits Nestlé (SPN)
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose
Overview
Brief Summary
Preclinical studies performed at Nestlé Research (NR) identified oleuropein as a novel activator of mitochondrial calcium import. This potentiated mitochondrial calcium uptake resulted in decreased phosphorylation of the enzyme pyruvate dehydrogenase (PDH), which is linked to its activation as a rate limiting enzyme for mitochondrial oxidation, as well as increasing mitochondrial oxygen consumption, resulting ultimately in decreases in muscle fatigue. In addition, NR demonstrated that during aging, mitochondrial calcium and oxygen consumption rates are decreased in isolated skeletal muscle fibers. The next step in the evidence development is to demonstrate efficacy of oleuropein for improved muscle energy and decreased physical fatigue in a healthy aging population.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
This is a single-centre, double-blind, placebo controlled, randomised 2-arms parallel group study.
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •50 to 70 years old
- •BMI 18.5-29.9 kg/m2
- •Healthy as per medical history and investigator's/ physician's judgement
- •Having given informed consent
Exclusion Criteria
- •Allergy/intolerance to the study product
- •\>5% body mass change in the previous 3 months
- •HbA1c ≥ 6.5%
- •Blood pressure \>140/90 mmHg
- •Participating in a structured (progressive) exercise program
- •Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes
- •Diagnosed musculoskeletal disorders
- •Chronic use of gastric acid suppressing medication
- •Unauthorized concomitant medications such as calcium antagonists (e.g. valproate), oral corticosteroids, anything that will prevent subjects from safely completing the study according to the investigator or medications / drugs known interfering with the expected mechanism of action of IP or to affect the outcome parameters
- •Alcohol (intake higher than 3 servings per day. One serving is 0.4 dl of alcohol, 1 dl of wine, or 3 dl of beer) or drug abuse
Outcomes
Primary Outcomes
Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose
Time Frame: Acute effect after first product intake + chronic effect after 36 days of intake
measured by biochemical assay analysis
Exploratory outcomes- to evaluate the changes of fatigue between oleuropein and placebo groups following 1 single dose
Time Frame: After 4 weeks of supplementation
measured using Biodex dynamometer
Exploratory outcomes - to evaluate the changes of fatigue between oleuropein and placebo groups
Time Frame: Chronic effect (after 29 days of supplementation)
measured using Biodex dynamometer
Exploratory outcomes - to evaluate the changes Mitocondrial respiration between oleuropein and placebo groups following 1 single dose
Time Frame: Acute effect after first product intake + chronic effect after 36 days of intake
measured the rates of oxygen consumption (respiration or JO2) using Oroboros Oxygraph 2K systems with physiological ADP concentrations using permeabilized muscle fibres.
Exploratory outcomes - to evaluate the changes of Pyruvate dehydrogenase activation between oleuropein and placebo groups
Time Frame: Chronic effect (after 36 days of supplementation)
measured by biochemical assay analysis
Exploratory outcomes - To evaluate the changes of Mitochondrial respiration between oleuropein and placebo groups
Time Frame: Chronic effect (after 36 days of supplementation)
measured the rates of oxygen consumption (respiration or JO2) using Oroboros Oxygraph 2K systems with physiological ADP concentrations using permeabilized muscle fibres.
Secondary Outcomes
- Exploratory outcomes - to evaluate the changes of glucose concentration between oleuropein and placebo groups following 1 single dose(Acute effect after first product intake + chronic effect after 36 days of intake)
- Exploratory outcomes - to evaluate the changes of oleuropein metabolites between oleuropein and placebo groups following 1 single dose(Acute effect after first product intake + chronic effect after 36 days of intake)
- Exploratory outcomes - to evaluate the changes in glucose concentration between oleuropein and placebo groups(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes - to evaluate the changes Blood glucose, insulin, free fatty acid concentrations -between oleuropein and placebo groups following 1 single dose(Acute effect after first product intake + chronic effect after 36 days of intake)
- Exploratory outcomes - to evaluate the changes of blood pressure between oleuropein and placebo groups following 1 single dose(Acute effect after first product intake + chronic effect after 36 days of intake)
- Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes to evaluate the changes in body composition between oleuropein and placebo groups(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes - to evaluate the changes of free fatty acid concentration between oleuropein and placebo groups following 1 single dose(Acute effect after first product intake + chronic effect after 36 days of intake)
- Exploratory outcomes - to evaluate the changes of anti-inflammatory markers between oleuropein and placebo groups(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes - to evaluate the changes of Antioxidant markers between oleuropein and placebo groups(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes - to evaluate the changes of insulin concentration between oleuropein and placebo groups(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes - to evaluate the changes in Strength between oleuropein and placebo groups(After 4 weeks of supplementation)
- Exploratory outcomes - to evaluate the changes of whole body respiratory exchange ratio (RER) between oleuropein and placebo groups following 1 single dose(Acute effect after first product intake+ chronic effect after 36 days of intake)
- Exploratory outcomes - to evaluate the changes of free fatty acid concentration between oleuropein and placebo groups(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes - Whole body respiratory exchange ratio - To evaluate the changes of Whole body respiratory exchange ratio (RER) between oleuropein and placebo groups(Chronic effect (after 36 days of supplementation))
- Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators oleuropein and placebo groups(Chronic effect (after 36 days of supplementation))
- Exploratory outcomes to evaluate the changes of strenght between oleuropein(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes - to evaluate the changes in the fatigue perception and mood state pre/post Biodex measurement between oleuropein and placebo groups(Chronic effect (after 29 days of supplementation))
- Exploratory outcomes - To evaluate the changes of oleuropein metabolites between oleuropein and placebo groups(Chronic effect (after 36 days of supplementation))
- Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators of muscle metabolism between oleuropein and placebo groups(Chronic effect (after 36 days of supplementation))