The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity in Middle-aged Adults

Overview

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.

Full Title of Study: “The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity: a Randomized Controlled Parallel Intervention Study in Healthy Overweight Individuals”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2022

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

Interventions

  • Dietary Supplement: Sweet orange and pomegranate extract
    • From the daily 650mg total supplementation of the investigational product, 250 mg will be of pomegranate extract containing 100mg of punicalagin. The remaining 400 mg will consist of sweet orange peel extract containing 360 mg of hesperidin.
  • Other: Maltodextrin control
    • Supplementation with 760 mg maltodextrin

Arms, Groups and Cohorts

  • Experimental: Sweet orange and pomegranate extract
    • Supplementation
  • Placebo Comparator: Maltodextrin
    • Supplementation

Clinical Trial Outcome Measures

Primary Measures

  • Change in endurance capacity
    • Time Frame: 12 weeks
    • An Ekblom-bak cycling test is used to estimate the maximal oxygen consumption

Secondary Measures

  • Change in Daily physical activity
    • Time Frame: 12 weeks
    • Measured with an accelerometer
  • Change in Handgrip strength
    • Time Frame: 12 weeks
    • Measured with a dynamometer
  • Change in Self reported quality of life
    • Time Frame: 12 weeks
    • Measured with the World Health Organization Quality of Life (WHO-QOL-100) questionnaire. For 6 domains (including physical, psychological, level of independence, social relationships, environment and religion/personal beliefs), a score will be calculated between 2 – 40 in which a higher score indicates better quality of life.
  • Change in General health
    • Time Frame: 12 weeks
    • Measured with the 36-Item Short Form Health Survey. For 4 domains (including functional status, wellbeing, general health and change in health), a score will be calculated between 0 – 100 in which a higher score indicates better health.
  • Change in Vitality
    • Time Frame: 12 weeks
    • Measured with the vita-16 questionnaire. For 4 domains (including energy, motivation, resilience and overall vitality), a score will be calculated between 1 – 7 in which a higher score indicates higher vitality.
  • Change in Glucose levels
    • Time Frame: 12 weeks
    • Measured in blood samples
  • Change in Cholesterol levels
    • Time Frame: 12 weeks
    • Measured in blood samples
  • Change in Triglyceride levels
    • Time Frame: 12 weeks
    • Measured in blood samples
  • Change in Insulin levels
    • Time Frame: 12 weeks
    • Measured in blood samples
  • Change in Cortisol levels
    • Time Frame: 12 weeks
    • Measured in blood samples
  • Change in C-reactive protein levels
    • Time Frame: 12 weeks
    • Measured in blood samples
  • Change in Antioxidative capacity
    • Time Frame: 12 weeks
    • Measured with a TEAC assay in blood
  • Change in Cell elongation index
    • Time Frame: 12 weeks
    • Measured with immunohistochemistry in muscle tissue samples
  • Change in Muscle proliferation (marker Pax7)
    • Time Frame: 12 weeks
    • Measured with qPCR in muscle tissue samples
  • Change in Muscle differentiation (marker MyoD)
    • Time Frame: 12 weeks
    • Measured with qPCR in muscle tissue samples
  • Change in Muscle differentiation (marker Myogenin)
    • Time Frame: 12 weeks
    • Measured with qPCR in muscle tissue samples
  • Change in Muscle differentiation (marker Myosin Heavy Chain)
    • Time Frame: 12 weeks
    • Measured with qPCR in muscle tissue samples
  • Change in Muscle mitochondrial biogenesis (marker PGC1alpha)
    • Time Frame: 12 weeks
    • Measured with qPCR in muscle tissue samples
  • Change in Muscle metabolism (marker Glut4)
    • Time Frame: 12 weeks
    • Measured with qPCR in muscle tissue samples
  • Change in Muscle redox biology (marker GCLC)
    • Time Frame: 12 weeks
    • Measured with qPCR in muscle tissue samples
  • Change in Muscle redox biology (marker Hmox1)
    • Time Frame: 12 weeks
    • Measured with qPCR in muscle tissue samples

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Maastricht University
  • Collaborator
    • BioActor B.V.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Freddy Troost, Dr., +31(0)43 3884296, f.troost@maastrichtuniversity.nl

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