- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00858728
Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly (ADIT)
December 1, 2021 updated by: Jayne Woodside, PhD, Queen's University, Belfast
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Co Antrim
-
Belfast, Co Antrim, United Kingdom, BT12 6BJ
- Queen's University Belfast
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 65-85 years
- Habitual consumption of fruit and vegetables <= 2 portions daily
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
5 portions fruit and vegetables/day
|
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).
|
|
Other: 2
2 portions fruit and vegetables/day
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination
Time Frame: 16 weeks
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in other markers of immune function
Time Frame: 16 weeks
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Neville 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.
- Gibson 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
March 9, 2009
First Submitted That Met QC Criteria
March 9, 2009
First Posted (Estimate)
March 10, 2009
Study Record Updates
Last Update Posted (Actual)
December 16, 2021
Last Update Submitted That Met QC Criteria
December 1, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 06/NIR03/64
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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