Immune FunctionADITNCT00858728
Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly
A study testing 5 portions and 2 portions in people with Immune Function, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
The immune system undergoes a range of changes as individuals become elderly. These may manifest as an increasing susceptibility to infection or a tendency to develop autoimmune or malignant disease. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Function
- What is being tested?
- 5 portions and 2 portions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2006to Sep 2009
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65-85 years
- Habitual consumption of fruit and vegetables <= 2 portions daily
Who cannot join
- Those on special diets, taking nutritional supplements or medications known to affect immune function or absorption of nutrients
- Excessive alcohol consumption (>28 U/week men or >21 U/week women)
- BMI>35 kg/m2
- History of diabetes or dementia
- Pneumovax II vaccination within previous 2 years
- Inability to provide informed consent
- Any other problem which would prevent adherence to a high fruit and vegetable diet
- Recent infection (<3 weeks since completion of any antibiotic course or symptoms of viral illness)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast
Belfast, Co Antrim, BT12 6BJ
About this study
Official title: Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly: a Randomised Controlled Trial
The immune system undergoes a range of changes as individuals become elderly. These may manifest as an increasing susceptibility to infection or a tendency to develop autoimmune or malignant disease. Multiple underlying factors contribute to this phenomenon of immunological aging, and in this study the investigators will examine the possibility that inadequate diet may be one such contributing factor. Fruit and vegetable intake, which can be low in the elderly, is associated with reduced chronic disease risk. This proposal will test the hypothesis that increased fruit and vegetable intake may positively affect clinically relevant measures of immune function. One hundred healthy volunteers aged 65-85 years following a low fruit and vegetable diet (<=2 portions/d) will be recruited and randomised to continue following their normal diet, or to consume at least 5 portions of fruit and vegetables daily for 16 weeks. Immune function and biochemical markers of nutritional status will be assessed before and after the intervention period.
- Conditions
- Immune Function
- Being tested
- 5 portions, 2 portions
- Keywords
- Natural killer cell cytotoxicity, Antibody response, Tetanus toxoid vaccination, Pneumovax II vaccination, Total serum immunoglobulins, IgG subclasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 portionsBehavioural
Subjects randomised to the intervention group will be provided with a selection of fruit and vegetables once a week (from a local supermarket) and will be asked to consume 5 portions of fruit and vegetables per day. For the purposes of this study, a portion will be as defined by the Food Standards Agency, i.e. an 80 g serving (one apple, orange or banana, or 3 heaped tablespoons of vegetables).
2 portionsBehavioural
Subjects randomised to the control group will be provided with a selection of fruit and vegetables once a week (from a local supermarket) and will be asked to consume 2 portions of fruit and vegetables per day. For the purposes of this study, a portion will be as defined by the Food Standards Agency, i.e. an 80 g serving (one apple, orange or banana, or 3 heaped tablespoons of vegetables).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5 portions fruit and vegetables/day Receives: Behavioral: 5 portions |
| 2 | Other | 2 portions fruit and vegetables/day Receives: Behavioral: 2 portions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination
Measured: 16 weeks
Secondary outcomes (1)
Change in other markers of immune function
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startOct 2006
- Primary completionDec 2008
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Immune FunctionStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayne Woodside, PhD, Queen's University, Belfast
- Investigators
- Jayne V Woodside, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858728
- Sponsor's protocol ID
- 06/NIR03/64
- Acronym
- ADIT
- Status last verified
- Dec 2021
- First submitted
- 9 Mar 2009
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Neville CE, McKinley MC, Draffin CR, Gallagher NE, Appleton KM, Young IS, Edgar JD, Woodside JV. Participating in a fruit and vegetable intervention trial improves longer term fruit and vegetable consumption and barriers to fruit and vegetable consumption: a follow-up of the ADIT study. Int J Behav Nutr Phys Act. 2015 Dec 18;12:158. doi: 10.1186/s12966-015-0311-4.
PubMed 26684653Neville CE, Young IS, Gilchrist SE, McKinley MC, Gibson A, Edgar JD, Woodside JV. Effect of increased fruit and vegetable consumption on physical function and muscle strength in older adults. Age (Dordr). 2013 Dec;35(6):2409-22. doi: 10.1007/s11357-013-9530-2. Epub 2013 Apr 2.
PubMed 23543264Gibson A, Edgar JD, Neville CE, Gilchrist SE, McKinley MC, Patterson CC, Young IS, Woodside JV. Effect of fruit and vegetable consumption on immune function in older people: a randomized controlled trial. Am J Clin Nutr. 2012 Dec;96(6):1429-36. doi: 10.3945/ajcn.112.039057. Epub 2012 Nov 7.
PubMed 23134881
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00858728
- Acronym / sponsor ID
- ADIT / 06/NIR03/64
- Conditions
- Immune Function
- Keywords
- Natural killer cell cytotoxicity, Antibody response, Tetanus toxoid vaccination, Pneumovax II vaccination, Total serum immunoglobulins, IgG subclasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 10 Mar 2009 (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 immune system undergoes a range of changes as individuals become elderly. These may manifest as an increasing susceptibility to infection or a tendency to develop autoimmune or malignant disease. Multiple underlying factors contribute to this phenomenon of immunological aging, and in this study the investigators will examine the possibility that inadequate diet may be one such contributing factor. Fruit and vegetable intake, which can be low in the elderly, is associated with reduced chronic disease risk. This proposal will test the hypothesis that increased fruit and vegetable intake may positively affect clinically relevant measures of immune function. One hundred healthy volunteers aged 65-85 years following a low fruit and vegetable diet (<=2 portions/d) will be recruited and randomised to continue following their normal diet, or to consume at least 5 portions of fruit and vegetables daily for 16 weeks. Immune function and biochemical markers of nutritional status will be assessed before and after the intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: 5 portions5 portions fruit and vegetables/day |
| 2 | Other | Behavioral: 2 portions2 portions fruit and vegetables/day |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65-85 years
- Habitual consumption of fruit and vegetables <= 2 portions daily
Key exclusion criteria (8 listed)
- Those on special diets, taking nutritional supplements or medications known to affect immune function or absorption of nutrients
- Excessive alcohol consumption (>28 U/week men or >21 U/week women)
- BMI>35 kg/m2
- History of diabetes or dementia
- Pneumovax II vaccination within previous 2 years
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 |
|---|---|---|
| 5 portionsSubjects randomised to the intervention group will be provided with a selection of fruit and vegetables once a week (from a local supermarket) and will be asked to consume 5 portions of fruit and vegetables per day. For the purposes of this study, a portion will be as defined by the Food Standards Agency, i.e. an 80 g serving (one apple, orange or banana, or 3 heaped tablespoons of vegetables). | Behavioural | 1 |
| 2 portionsSubjects randomised to the control group will be provided with a selection of fruit and vegetables once a week (from a local supermarket) and will be asked to consume 2 portions of fruit and vegetables per day. For the purposes of this study, a portion will be as defined by the Food Standards Agency, i.e. an 80 g serving (one apple, orange or banana, or 3 heaped tablespoons of vegetables). | Behavioural | 2 |
Primary outcome
Change in natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination
Time frame: 16 weeks
1 secondary outcome
Change in other markers of immune function
Time frame: 16 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 16 Dec 2021.
- Derived from this study: PubMed 26684653Neville CE, McKinley MC, Draffin CR, Gallagher NE, Appleton KM, Young IS, Edgar JD, Woodside JV. Participating in a fruit and vegetable intervention trial improves longer term fruit and vegetable consumption and barriers to fruit and vegetable consumption: a follow-up of the ADIT study. Int J Behav Nutr Phys Act. 2015 Dec 18;12:158. doi: 10.1186/s12966-015-0311-4.
- Derived from this study: PubMed 23543264Neville CE, Young IS, Gilchrist SE, McKinley MC, Gibson A, Edgar JD, Woodside JV. Effect of increased fruit and vegetable consumption on physical function and muscle strength in older adults. Age (Dordr). 2013 Dec;35(6):2409-22. doi: 10.1007/s11357-013-9530-2. Epub 2013 Apr 2.
- Derived from this study: PubMed 23134881Gibson A, Edgar JD, Neville CE, Gilchrist SE, McKinley MC, Patterson CC, Young IS, Woodside JV. Effect of fruit and vegetable consumption on immune function in older people: a randomized controlled trial. Am J Clin Nutr. 2012 Dec;96(6):1429-36. doi: 10.3945/ajcn.112.039057. Epub 2012 Nov 7.
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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.
Jayne V Woodside, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 portions and 2 portions in people with Immune Function, run by Queen's University, Belfast 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 2 inclusion and 8 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 Dec 2021. 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. 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 natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination (time frame: 16 weeks). 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 NCT00858728, which also lists 3 linked publications.
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 Dec 2021.