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
  Purpose

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.


Condition Intervention Phase
Immune Function
Behavioral: 5 portions
Behavioral: 2 portions
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Queen's University, Belfast:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Change in other markers of immune function [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: October 2006
Study Completion Date: September 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
5 portions fruit and vegetables/day
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).
2
2 portions fruit and vegetables/day
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).

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858728

Locations
United Kingdom
Queen's University Belfast
Belfast, Co Antrim, United Kingdom, BT12 6BJ
Sponsors and Collaborators
Queen's University, Belfast
Investigators
Principal Investigator: Jayne V Woodside, PhD Queen's University, Belfast
  More Information

No publications provided by Queen's University, Belfast

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Jayne Woodside, Queen's University Belfast
ClinicalTrials.gov Identifier: NCT00858728     History of Changes
Other Study ID Numbers: 06/NIR03/64
Study First Received: March 9, 2009
Last Updated: July 22, 2010
Health Authority: United Kingdom: Food Standards Agency

Keywords provided by Queen's University, Belfast:
Natural killer cell cytotoxicity
Antibody response
Tetanus toxoid vaccination
Pneumovax II vaccination
Total serum immunoglobulins
IgG subclasses

ClinicalTrials.gov processed this record on October 16, 2014