Cardiovascular DiseasesNCT01141803
Effect of Apple and Apple Pomace on Inflammation and Cholesterol Metabolism in Healthy Overweight
A study testing Apples and Apple pomace in people with Cardiovascular Diseases, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The investigators will assess the protective and antiinflammatory effects of processed fruit and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded parallel study is conducted to investigate the protective effects of fruit fibre on colonic epithelium. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Apples and Apple pomace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to Oct 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- BMI over 30
- No daily medication
- Not strenuous exercise > 10hours/week
- No blood donation 3 months before or during the study
Who cannot join
- Smoking
- Simultaneous participation in other research projects
- Use of any dietary supplements
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, LIFE, University of Copenhagen
Frederiksberg, 1951
About this study
Official title: Isafruit: Nutrigenomics in Overweight
The investigators will assess the protective and antiinflammatory effects of processed fruit and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded parallel study is conducted to investigate the protective effects of fruit fibre on colonic epithelium. Relevant signalling pathways related to cholesterol metabolism, vascular inflammation, oxidative defence, apoptosis and sterol metabolism will be targeted. Volunteers are randomly assigned one of three groups. They are instructed to follow a polyphenol and pectin restricted diet for six weeks. The last four weeks in this six week period, the restricted diet is supplemented with whole apples (550g/day), apple pomace (22g/day) or nothing. Blood, urine, faecal samples and colon biopsies are collected before and after the four weeks intervention period.
- Conditions
- Cardiovascular Diseases
- Being tested
- Apples, Apple pomace
- Keywords
- Apple, Apple pomace, Metabolomics, Gene expression, Lipid metabolism, Prevention, Antiinflammatory effect
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApplesDietary supplement
550g of apples/day
Apple pomaceDietary supplement
22g apple pomace/day
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| Apples | Active comparator | Not described Receives: Dietary Supplement: Apples |
| Apple pomace | Active comparator | Not described Receives: Dietary Supplement: Apple pomace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Measured: Measured at week 2
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Measured: Measured at week 6
Secondary outcomes (16)
Blood pressure
Measured: Measured at week 2
Blood pressure
Measured: Measured at week 6
Anthropometry (weight, height, waist and hip circumference)
Measured: Measured at week 2
Anthropometry (weight, height, waist and hip circumference)
Measured: Measured at week 6
Inflammatory marker (hs-CRP)
Measured: Measured at week 2
Inflammatory marker (hs-CRP)
Measured: Measured at week 6
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
Measured: Measured at week 2
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
Measured: Measured at week 6
Urine analyses (metabolomics)
Measured: Measured at week 2
Urine analyses (metabolomics)
Measured: Measured at week 6
Serum insulin, IGF-1 and IGFBP-3 levels
Measured: Measured at week 2
Serum insulin, IGF-1 and IGFBP-3 levels
Measured: Measured at week 6
Gene expression in white blood cells and colon tissue
Measured: Measured at week 2
Gene expression in white blood cells and colon tissue
Measured: Measured at week 6
Enzyme activity in lysed erythrocytes (glutathione peroxidase)
Measured: Measured at week 2
Enzyme activity in lysed erythrocytes (glutathione peroxidase)
Measured: Measured at week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, Central Jutland Regional Hospital
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Susanne Bügel, PhD, Study director, Department of Human Nutrition, LIFE, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141803
- Sponsor's protocol ID
- M198
- Status last verified
- Jul 2016
- First submitted
- 8 Jun 2010
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isafruit: Nutrigenomics in Overweight
- ClinicalTrials.gov ID
- NCT01141803
- Acronym / sponsor ID
- M198
- Conditions
- Cardiovascular Diseases
- Keywords
- Apple, Apple pomace, Metabolomics, Gene expression, Lipid metabolism, Prevention, Antiinflammatory effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Technical University of Denmark, Central Jutland Regional Hospital
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Jun 2010 (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.
The investigators will assess the protective and antiinflammatory effects of processed fruit and fruit fibre in overweight subjects with signs of metabolic syndrome. A single-blinded parallel study is conducted to investigate the protective effects of fruit fibre on colonic epithelium. Relevant signalling pathways related to cholesterol metabolism, vascular inflammation, oxidative defence, apoptosis and sterol metabolism will be targeted. Volunteers are randomly assigned one of three groups. They are instructed to follow a polyphenol and pectin restricted diet for six weeks. The last four weeks in this six week period, the restricted diet is supplemented with whole apples (550g/day), apple pomace (22g/day) or nothing. Blood, urine, faecal samples and colon biopsies are collected before and after the four weeks intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| Apples | Active comparator | Dietary Supplement: Apples |
| Apple pomace | Active comparator | Dietary Supplement: Apple pomace |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy
- BMI over 30
- No daily medication
- Not strenuous exercise > 10hours/week
- No blood donation 3 months before or during the study
Key exclusion criteria (3 listed)
- Smoking
- Simultaneous participation in other research projects
- Use of any dietary supplements
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 |
|---|---|---|
| Apples550g of apples/day | Dietary supplement | Apples |
| Apple pomace22g apple pomace/day | Dietary supplement | Apple pomace |
Primary outcome
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Time frame: Measured at week 2
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol)
Time frame: Measured at week 6
16 secondary outcomes
Blood pressure
Time frame: Measured at week 2
Blood pressure
Time frame: Measured at week 6
Anthropometry (weight, height, waist and hip circumference)
Time frame: Measured at week 2
Anthropometry (weight, height, waist and hip circumference)
Time frame: Measured at week 6
Inflammatory marker (hs-CRP)
Time frame: Measured at week 2
Inflammatory marker (hs-CRP)
Time frame: Measured at week 6
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
Time frame: Measured at week 2
Faeces analyses (metabolomics, pH, bile acids, short-chain fatty acids)
Time frame: Measured at week 6
Urine analyses (metabolomics)
Time frame: Measured at week 2
Urine analyses (metabolomics)
Time frame: Measured at week 6
Serum insulin, IGF-1 and IGFBP-3 levels
Time frame: Measured at week 2
Serum insulin, IGF-1 and IGFBP-3 levels
Time frame: Measured at week 6
Gene expression in white blood cells and colon tissue
Time frame: Measured at week 2
Gene expression in white blood cells and colon tissue
Time frame: Measured at week 6
Enzyme activity in lysed erythrocytes (glutathione peroxidase)
Time frame: Measured at week 2
Enzyme activity in lysed erythrocytes (glutathione peroxidase)
Time frame: Measured at week 6
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 20 Jul 2016.
- Individual participant dataSharing planned: Yes
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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.
Susanne Bügel, PhD study director
Department of Human Nutrition, LIFE, University of Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apples and Apple pomace in people with Cardiovascular Diseases, run by University of Copenhagen at 1 site in Denmark.
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 5 inclusion and 3 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 20 Jul 2016. 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 Denmark. 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. 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?
Blood lipid profile (triacylglycerol and total-, LDL- and HDL-cholesterol) (time frame: Measured at week 2). The study lists 2 primary outcomes in all. 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 20 Jul 2016.