Vascular StiffnessNCT01963416
Effects of Fruit Consumption on Risk Factors of Chronic Disease
A study testing Orange juice, whole orange fruit and Processed whole orange in people with Vascular Stiffness, run by University of Reading at 1 site in United Kingdom.
Trial summary
Acute, randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 4 intervention arms consisting of control, orange juice, whole orange, and processed whole orange to determine the effect of the interventions on the primary measure of flow mediated dilatation (FMD) and additional… Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Stiffness
- What is being tested?
- Orange juice, whole orange fruit and Processed whole orange
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2012to Dec 2012
- 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 30 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males due to potential hormonal fluctuations in female subjects
- Aged 30-65years
- Fasting total cholesterol in the upper half of the normal range (6.0-8.0 mmol/l) or triacylglycerol >0.8 mmol/l or a BMI 25-32 kg/m2.
- Not having suffered a myocardial infarction/stroke in the past 12 months
- Not diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
- Not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
Show all 13Show fewer
- Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
- No history of alcohol misuse
- Not planning or on a weight reducing regime
- Not taking any fish oil, fatty acid or vitamin and mineral supplements
- Non smokers
- Not suffering from depression as indicated by the Brief Symptom Inventory (Appendix 11).
- Not suffering from mild cognitive impairment or dementia according to the MMSE (score ≥ 25).
Who cannot join
- Females
- Medication for hypertension, hyperlipidaemia, inflammation or hypercoagulation
- Hypertension - ACE Inhibitors (e.g. Captopril, Cilazapril), Angiotensin Receptor Blockers (Valsartan), Calcium Channel Blockers (Amlodipine, Nicardipine), Diuretics (Chlortalidone) or Beta blockers (Sotalol, Bisoprolol).
- Cholesterol lowering (Pravastatin, Simuvustatin)
- Anticoagulants (Warfarin)
- Inflammation - NSAID's (Tiaprofenic acid, Sulindac, Ibuprofen), Corticosteroids(Betamethasone)
Show all 13Show fewer
- Strict vegetarians
- Smokers
- Those on or planning a weight reducing regime
- Blood glucose, haemaglobin or liver enzymes outside of the normal range
- Unable to consume study meals
- Those suffering from depression as indicated by the Brief Symptom Inventory (Appendix 11).
- Those suffering from mild cognitive impairment or dementia as indicated by the MMSE (score < 25).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled, Crossover in Design, Double Blind Clinical Trial Investigating the Effects of Whole Versus Processed Fruit Consumption on Risk Factors for Chronic Disease and Performance Indicators.
Acute, randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 4 intervention arms consisting of control, orange juice, whole orange, and processed whole orange to determine the effect of the interventions on the primary measure of flow mediated dilatation (FMD) and additional biomarkers of health. The study will also identify and quantify the main micronutrients and phytochemicals in each of the products and will identify and quantify the main micronutrients and phytochemicals and their metabolites in the subjects' plasma and/or urine. A subset of the study population (n=24) will be invited to participate in an additional arm of the main study which is summarised below.
- Conditions
- Vascular Stiffness
- Being tested
- macro- and micro-nutrient matched control (240 ml), Orange juice, whole orange fruit, Processed whole orange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macro- and micro-nutrient matched control (240 ml)Dietary supplement
Orange juiceDietary supplement
whole orange fruitDietary supplement
Processed whole orangeDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | macro- and micro-nutrient matched control (240 ml) Receives: Dietary Supplement: macro- and micro-nutrient matched control (240 ml) |
| Orange juice | Experimental | commercial orange juice (240 ml) Receives: Dietary Supplement: Orange juice |
| whole orange | Experimental | whole orange fruit (240 ml) Receives: Dietary Supplement: whole orange fruit |
| processed whole orange | Experimental | processed whole orange (240 ml) Receives: Dietary Supplement: Processed whole orange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow mediated dilation
Measured: change in Flow Mediated Dilation response between baseline and 6 hours
Secondary outcomes (9)
Postprandial plasma glucose
Measured: change in glucose from baseline to 2 hours
Postprandial insulin
Measured: change from baseline to 2 hours
global cognitive function
Measured: change from baseline to 6 hours
Blood pressure
Measured: change from baseline to 6 hours
postprandial non-esterified fatty acids
Measured: change from baseline to 6 hours
Postprandial triacylglycerol
Measured: change from baseline to 6 hours
total HDL/LDL
Measured: change from baseline to 6 hours
Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP)
Measured: change from baseline to 6 hours
LDL oxidation
Measured: change from baseline to 6h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular StiffnessStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- PepsiCo Global R&D
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963416
- Sponsor's protocol ID
- UOR-0001
- Status last verified
- Oct 2013
- First submitted
- 10 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dong H, Rendeiro C, Kristek A, Sargent LJ, Saunders C, Harkness L, Rowland I, Jackson KG, Spencer JP, Lovegrove JA. Addition of Orange Pomace to Orange Juice Attenuates the Increases in Peak Glucose and Insulin Concentrations after Sequential Meal Ingestion in Men with Elevated Cardiometabolic Risk. J Nutr. 2016 Jun;146(6):1197-203. doi: 10.3945/jn.115.226001. Epub 2016 May 11.
PubMed 27170728
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Crossover in Design, Double Blind Clinical Trial Investigating the Effects of Whole Versus Processed Fruit Consumption on Risk Factors for Chronic Disease and Performance Indicators.
- ClinicalTrials.gov ID
- NCT01963416
- Acronym / sponsor ID
- UOR-0001
- Conditions
- Vascular Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- PepsiCo Global R&D
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Oct 2013 (estimated)
- 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.
Acute, randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 4 intervention arms consisting of control, orange juice, whole orange, and processed whole orange to determine the effect of the interventions on the primary measure of flow mediated dilatation (FMD) and additional biomarkers of health. The study will also identify and quantify the main micronutrients and phytochemicals in each of the products and will identify and quantify the main micronutrients and phytochemicals and their metabolites in the subjects' plasma and/or urine. A subset of the study population (n=24) will be invited to participate in an additional arm of the main study which is summarised below.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: macro- and micro-nutrient matched control (240 ml)macro- and micro-nutrient matched control (240 ml) |
| Orange juice | Experimental | Dietary Supplement: Orange juicecommercial orange juice (240 ml) |
| whole orange | Experimental | Dietary Supplement: whole orange fruitwhole orange fruit (240 ml) |
| processed whole orange | Experimental | Dietary Supplement: Processed whole orangeprocessed whole orange (240 ml) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males due to potential hormonal fluctuations in female subjects
- Aged 30-65years
- Fasting total cholesterol in the upper half of the normal range (6.0-8.0 mmol/l) or triacylglycerol >0.8 mmol/l or a BMI 25-32 kg/m2.
- Not having suffered a myocardial infarction/stroke in the past 12 months
- Not diabetic (diagnosed or fasting glucose > 7 mmol/l) or suffer from other endocrine disorders
Key exclusion criteria (13 listed)
- Females
- Medication for hypertension, hyperlipidaemia, inflammation or hypercoagulation
- Strict vegetarians
- Smokers
- Those on or planning a weight reducing regime
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 |
|---|---|---|
| macro- and micro-nutrient matched control (240 ml) | Dietary supplement | Control |
| Orange juice | Dietary supplement | Orange juice |
| whole orange fruit | Dietary supplement | whole orange |
| Processed whole orange | Dietary supplement | processed whole orange |
Primary outcome
Flow mediated dilation
Time frame: change in Flow Mediated Dilation response between baseline and 6 hours
9 secondary outcomes
Postprandial plasma glucose
Time frame: change in glucose from baseline to 2 hours
Postprandial insulin
Time frame: change from baseline to 2 hours
global cognitive function
Time frame: change from baseline to 6 hours
Blood pressure
Time frame: change from baseline to 6 hours
postprandial non-esterified fatty acids
Time frame: change from baseline to 6 hours
Postprandial triacylglycerol
Time frame: change from baseline to 6 hours
total HDL/LDL
Time frame: change from baseline to 6 hours
Inflammatory status (IL1-beta; IL2; IL6; IL10; IFN-gamma; TNF-alpha; CRP)
Time frame: change from baseline to 6 hours
LDL oxidation
Time frame: change from baseline to 6h
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 16 Oct 2013.
- Derived from this study: PubMed 27170728Dong H, Rendeiro C, Kristek A, Sargent LJ, Saunders C, Harkness L, Rowland I, Jackson KG, Spencer JP, Lovegrove JA. Addition of Orange Pomace to Orange Juice Attenuates the Increases in Peak Glucose and Insulin Concentrations after Sequential Meal Ingestion in Men with Elevated Cardiometabolic Risk. J Nutr. 2016 Jun;146(6):1197-203. doi: 10.3945/jn.115.226001. Epub 2016 May 11.
Related trials for Vascular Stiffness
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
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 Orange juice, whole orange fruit and Processed whole orange in people with Vascular Stiffness, run by University of Reading at 1 site in United Kingdom.
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 13 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 16 Oct 2013. 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 United Kingdom. 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?
Flow mediated dilation (time frame: change in Flow Mediated Dilation response between baseline and 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01963416, which also lists 1 linked publication.
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 16 Oct 2013.