Exercise CapacityActiful2NCT05133778
The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity in Middle-aged Adults
A study testing Sweet orange and pomegranate extract in people with Exercise Capacity, run by Maastricht University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Capacity
- What is being tested?
- Sweet orange and pomegranate extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2021to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity: a Randomized Controlled Parallel Intervention Study in Healthy Overweight Individuals
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.
Read the 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
- Conditions
- Exercise Capacity
- Being tested
- Sweet orange and pomegranate extract, Maltodextrin control
- Keywords
- Sweet orange, Pomegranate, Polyphenols, Exercise capacity, Ekblom-bak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweet orange and pomegranate extractDietary supplement
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.
Maltodextrin controlOther
Supplementation with 760 mg maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Sweet orange and pomegranate extract | Experimental | Supplementation Receives: Dietary Supplement: Sweet orange and pomegranate extract |
| Maltodextrin | Placebo comparator | Supplementation Receives: Other: Maltodextrin control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endurance capacity
An Ekblom-bak cycling test is used to estimate the maximal oxygen consumption
Measured: 12 weeks
Secondary outcomes (21)
Change in Daily physical activity
Measured with an accelerometer
Measured: 12 weeks
Change in Handgrip strength
Measured with a dynamometer
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Change in Glucose levels
Measured in blood samples
Measured: 12 weeks
Change in Cholesterol levels
Measured in blood samples
Measured: 12 weeks
Change in Triglyceride levels
Measured in blood samples
Measured: 12 weeks
Change in Insulin levels
Measured in blood samples
Measured: 12 weeks
Change in Cortisol levels
Measured in blood samples
Measured: 12 weeks
Change in C-reactive protein levels
Measured in blood samples
Measured: 12 weeks
Change in Antioxidative capacity
Measured with a TEAC assay in blood
Measured: 12 weeks
Change in Cell elongation index
Measured with immunohistochemistry in muscle tissue samples
Measured: 12 weeks
Change in Muscle proliferation (marker Pax7)
Measured with qPCR in muscle tissue samples
Measured: 12 weeks
Change in Muscle differentiation (marker MyoD)
Measured with qPCR in muscle tissue samples
Measured: 12 weeks
Change in Muscle differentiation (marker Myogenin)
Measured with qPCR in muscle tissue samples
Measured: 12 weeks
Change in Muscle differentiation (marker Myosin Heavy Chain)
Measured with qPCR in muscle tissue samples
Measured: 12 weeks
Change in Muscle mitochondrial biogenesis (marker PGC1alpha)
Measured with qPCR in muscle tissue samples
Measured: 12 weeks
Change in Muscle metabolism (marker Glut4)
Measured with qPCR in muscle tissue samples
Measured: 12 weeks
Change in Muscle redox biology (marker GCLC)
Measured with qPCR in muscle tissue samples
Measured: 12 weeks
Change in Muscle redox biology (marker Hmox1)
Measured with qPCR in muscle tissue samples
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise CapacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled parallel trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- BioActor B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133778
- Sponsor's protocol ID
- Actiful2
- Acronym
- Actiful2
- Status last verified
- May 2025
- First submitted
- 26 Oct 2021
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sweet Orange and Pomegranate Extract Supplementation on Exercise Capacity: a Randomized Controlled Parallel Intervention Study in Healthy Overweight Individuals
- ClinicalTrials.gov ID
- NCT05133778
- Acronym / sponsor ID
- Actiful2 / Actiful2
- Conditions
- Exercise Capacity
- Keywords
- Sweet orange, Pomegranate, Polyphenols, Exercise capacity, Ekblom-bak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- BioActor B.V.
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled parallel trial
| Arm | Type | Receives |
|---|---|---|
| Sweet orange and pomegranate extract | Experimental | Dietary Supplement: Sweet orange and pomegranate extractSupplementation |
| Maltodextrin | Placebo comparator | Other: Maltodextrin controlSupplementation |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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))
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sweet orange and pomegranate extractFrom 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. | Dietary supplement | Sweet orange and pomegranate extract |
| Maltodextrin controlSupplementation with 760 mg maltodextrin | Other | Maltodextrin |
Primary outcome
Change in endurance capacity
Time frame: 12 weeks
An Ekblom-bak cycling test is used to estimate the maximal oxygen consumption
21 secondary outcomes
Change in Daily physical activity
Time frame: 12 weeks
Change in Handgrip strength
Time frame: 12 weeks
Change in Self reported quality of life
Time frame: 12 weeks
Change in General health
Time frame: 12 weeks
Change in Vitality
Time frame: 12 weeks
Change in Glucose levels
Time frame: 12 weeks
Change in Cholesterol levels
Time frame: 12 weeks
Change in Triglyceride levels
Time frame: 12 weeks
Change in Insulin levels
Time frame: 12 weeks
Change in Cortisol levels
Time frame: 12 weeks
Change in C-reactive protein levels
Time frame: 12 weeks
Change in Antioxidative capacity
Time frame: 12 weeks
Change in Cell elongation index
Time frame: 12 weeks
Change in Muscle proliferation (marker Pax7)
Time frame: 12 weeks
Change in Muscle differentiation (marker MyoD)
Time frame: 12 weeks
Change in Muscle differentiation (marker Myogenin)
Time frame: 12 weeks
Change in Muscle differentiation (marker Myosin Heavy Chain)
Time frame: 12 weeks
Change in Muscle mitochondrial biogenesis (marker PGC1alpha)
Time frame: 12 weeks
Change in Muscle metabolism (marker Glut4)
Time frame: 12 weeks
Change in Muscle redox biology (marker GCLC)
Time frame: 12 weeks
Change in Muscle redox biology (marker Hmox1)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweet orange and pomegranate extract in people with Exercise Capacity, run by Maastricht University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endurance capacity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.