Clinical trial NCT00858728: Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly
Official title: Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Function
Keywords: Natural killer cell cytotoxicity
Antibody response
Tetanus toxoid vaccination
Pneumovax II vaccination
Total serum immunoglobulins
IgG subclasses
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 83
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in other markers of immune function
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Co Antrim
Study officials:
affiliation: Queen's University, Belfast
name: Jayne V Woodside, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.