Clinical trial NCT05133778: The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity in Middle-aged Adults
Official title: The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity: a Randomized Controlled Parallel Intervention Study in Healthy Overweight Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Capacity
Keywords: Sweet orange
Pomegranate
Polyphenols
Exercise capacity
Ekblom-bak
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: BioActor B.V.
First posted: 2021-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled parallel trial
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to investigate the effect of 12-week long daily administration of a sweet orange and pomegranate extract on exercise capacity in healthy adults.

Detailed description: Background of the study: Polyphenols have been studied for their protective effect against the development of ROS-related diseases like cancers, cardiovascular diseases, diabetes, osteoporosis, and neurodegenerative diseases. The combined supplementation of pomegranate and sweet orange polyphenols could be an effective strategy to improve exercise performance, due to their antioxidant character and ability to stimulate NO production, to stimulate mitochondrial biogenesis and to accelerate muscle repair and decrease muscle tissue damage. The study aims to assess the effect of a combined supplementation of pomegranate and sweet orange extract on exercise capacity, physical activity, muscle strength and quality of life in healthy adults.

Objective of the study: The aim of the present study is to investigate the effect of 12-week long daily administration of a sweet orange and pomegranate extract on exercise capacity in healthy adults (40 - 65 y).

Study design: Randomized, double-blind, placebo-controlled parallel trial

Study population: Healthy, overweight, sedentary adults between 40 and 65 years old.

Intervention: 12-week supplementation with 650 mg sweet orange and pomegranate extract (2 capsules per day) compared to placebo (760 mg maltodextrin).

Primary outcome of the study: Change in aerobic capacity (VO2max), assessed with an Ekblom-Bak submaximal cycling test.

Secondary study parameters/outcome of the study:

* Daily physical activity as determined by accelerometer
* Dietary intake as measured by a 3-day food record
* Handgrip strength
* Muscle cell proliferation and differentiation and mitochondrial biogenesis assessed in skeletal muscle biopsies
* Quality of Life as measured by the WHO-QOL-100 questionnaire
* General health as measured by SF-36 questionnaire
* Vitality as measured by the Dutch Vitality Questionnaire (Vita-16)
* Cardiometabolic health biomarkers, cortisol, C-reactive protein determined with ELISA
* Antioxidative capacity measured with a Trolox equivalent antioxidant capacity (TEAC) assay

Eligibility criteria: Inclusion Criteria:

* Healthy male/female (based on medical history provided during a general health questionnaire)
* Age between 40 - 65 yrs
* Overweight (BMI ≥25 to ≤29.9 kg/m2)
* Sedentary subjects (Low Level \[\<600 MET-minutes/week\] as assessed by the Physical Activity Questionnaire (IPAQ))

Exclusion Criteria:

* Allergy to test product/control or citrus fruits and pomegranate
* Medical conditions that might interfere with endpoints or compromise participant safety during testing (e.g. Cardiovascular diseases, cancer, Parkinson's disease, Gastrointestinal diseases or abdominal surgery) to be decided by the principal investigator
* Use of medication that might interfere with endpoints (i.e.: β-blockers, antioxidant, antidepressants)
* High fasting blood glucose (FBG ≥100 mg/dL)
* Recent skeletal muscle injury in less than one month before the start of the study
* Use of antibiotics within 3 months prior to Visit 2
* Use of probiotics or supplements containing vitamins, minerals or antioxidants four weeks prior to Visit 2
* Regular smoking (including use of e-cigarettes)
* Inability to correctly perform the PA test during screening/familiarization
* Abuse of alcohol (alcohol consumption \>20 units/week) and/or drugs
* Plans to change diet or medication for the duration of the study
* Treatment with an investigational drug (phase 1-3) 180 days before the start of the study
* Inability to understand study information and/or communicate with staff

Primary outcomes:
measure: Change in endurance capacity
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Daily physical activity
timeFrame: 12 weeks
measure: Change in Handgrip strength
timeFrame: 12 weeks
measure: Change in Self reported quality of life
timeFrame: 12 weeks
measure: Change in General health
timeFrame: 12 weeks
measure: Change in Vitality
timeFrame: 12 weeks
measure: Change in Glucose levels
timeFrame: 12 weeks
measure: Change in Cholesterol levels
timeFrame: 12 weeks
measure: Change in Triglyceride levels
timeFrame: 12 weeks
measure: Change in Insulin levels
timeFrame: 12 weeks
measure: Change in Cortisol levels
timeFrame: 12 weeks
measure: Change in C-reactive protein levels
timeFrame: 12 weeks
measure: Change in Antioxidative capacity
timeFrame: 12 weeks
measure: Change in Cell elongation index
timeFrame: 12 weeks
measure: Change in Muscle proliferation (marker Pax7)
timeFrame: 12 weeks
measure: Change in Muscle differentiation (marker MyoD)
timeFrame: 12 weeks
measure: Change in Muscle differentiation (marker Myogenin)
timeFrame: 12 weeks
measure: Change in Muscle differentiation (marker Myosin Heavy Chain)
timeFrame: 12 weeks
measure: Change in Muscle mitochondrial biogenesis (marker PGC1alpha)
timeFrame: 12 weeks
measure: Change in Muscle metabolism (marker Glut4)
timeFrame: 12 weeks
measure: Change in Muscle redox biology (marker GCLC)
timeFrame: 12 weeks
measure: Change in Muscle redox biology (marker Hmox1)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
References: