Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly (ADIT)

This study has been completed.
Sponsor:
Information provided by:
Queen's University, Belfast
ClinicalTrials.gov Identifier:
NCT00858728
First received: March 9, 2009
Last updated: July 22, 2010
Last verified: July 2010

March 9, 2009
July 22, 2010
October 2006
December 2008   (final data collection date for primary outcome measure)
Change in natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00858728 on ClinicalTrials.gov Archive Site
Change in other markers of immune function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Immune Function
  • Behavioral: 5 portions
    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).
  • Behavioral: 2 portions
    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).
  • Experimental: 1
    5 portions fruit and vegetables/day
    Intervention: Behavioral: 5 portions
  • 2
    2 portions fruit and vegetables/day
    Intervention: Behavioral: 2 portions
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
September 2009
December 2008   (final data collection date for primary outcome measure)

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)
Both
65 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00858728
06/NIR03/64
No
Dr Jayne Woodside, Queen's University Belfast
Queen's University, Belfast
Not Provided
Principal Investigator: Jayne V Woodside, PhD Queen's University, Belfast
Queen's University, Belfast
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP