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

Exercise Capacity Clinical Trial

— Actiful2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133778
• Other study ID #: Actiful2
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Maastricht University
• Contact: Freddy Troost, Dr.
• Phone: +31(0)43 3884296
• Email: f.troost[@]maastrichtuniversity.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.: ß-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

Related Conditions & MeSH terms

• Exercise Capacity

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University	BioActor B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in endurance capacity	An Ekblom-bak cycling test is used to estimate the maximal oxygen consumption	12 weeks
Secondary	Change in Daily physical activity	Measured with an accelerometer	12 weeks
Secondary	Change in Handgrip strength	Measured with a dynamometer	12 weeks
Secondary	Change in Self reported quality of life	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.	12 weeks
Secondary	Change in General health	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.	12 weeks
Secondary	Change in Vitality	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.	12 weeks
Secondary	Change in Glucose levels	Measured in blood samples	12 weeks
Secondary	Change in Cholesterol levels	Measured in blood samples	12 weeks
Secondary	Change in Triglyceride levels	Measured in blood samples	12 weeks
Secondary	Change in Insulin levels	Measured in blood samples	12 weeks
Secondary	Change in Cortisol levels	Measured in blood samples	12 weeks
Secondary	Change in C-reactive protein levels	Measured in blood samples	12 weeks
Secondary	Change in Antioxidative capacity	Measured with a TEAC assay in blood	12 weeks
Secondary	Change in Cell elongation index	Measured with immunohistochemistry in muscle tissue samples	12 weeks
Secondary	Change in Muscle proliferation (marker Pax7)	Measured with qPCR in muscle tissue samples	12 weeks
Secondary	Change in Muscle differentiation (marker MyoD)	Measured with qPCR in muscle tissue samples	12 weeks
Secondary	Change in Muscle differentiation (marker Myogenin)	Measured with qPCR in muscle tissue samples	12 weeks
Secondary	Change in Muscle differentiation (marker Myosin Heavy Chain)	Measured with qPCR in muscle tissue samples	12 weeks
Secondary	Change in Muscle mitochondrial biogenesis (marker PGC1alpha)	Measured with qPCR in muscle tissue samples	12 weeks
Secondary	Change in Muscle metabolism (marker Glut4)	Measured with qPCR in muscle tissue samples	12 weeks
Secondary	Change in Muscle redox biology (marker GCLC)	Measured with qPCR in muscle tissue samples	12 weeks
Secondary	Change in Muscle redox biology (marker Hmox1)	Measured with qPCR in muscle tissue samples	12 weeks