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

NCT00858728 | Completed

• 1 other identifier: 06/NIR03/64
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Function

Keywords

Natural killer cell cytotoxicity; Antibody response; Tetanus toxoid vaccination; Pneumovax II vaccination; Total serum immunoglobulins; IgG subclasses

Outcome Measures

Primary Outcomes (1)

• Change in natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination

  16 weeks

Secondary Outcomes (1)

• Change in other markers of immune function

  16 weeks

Study Arms (2)

1

EXPERIMENTAL

5 portions fruit and vegetables/day

Behavioral: 5 portions

2

OTHER

2 portions fruit and vegetables/day

Behavioral: 2 portions

Interventions

5 portions BEHAVIORAL

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).

1

2 portions BEHAVIORAL

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).

2

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65-85 years
• Habitual consumption of fruit and vegetables \<= 2 portions daily

You may not qualify if:

• 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)

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Queen's University Belfast

Belfast, Co Antrim, BT12 6BJ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 26684653 DERIVED

• 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.

  PMID: 23543264 DERIVED

• 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.

  PMID: 23134881 DERIVED

Study Officials

• Jayne V Woodside, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 10, 2009
• Study Start: October 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: September 1, 2009
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

GB (1)