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

NCT ID: NCT00858728

Last Updated: 2021-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2009-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

5 portions fruit and vegetables/day

Group Type: EXPERIMENTAL

5 portions

Intervention Type: 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).

2

2 portions fruit and vegetables/day

Group Type: OTHER

2 portions

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Jayne Woodside, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jayne V Woodside, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Queen's University Belfast

Belfast, Co Antrim, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26684653 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23543264 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23134881 (View on PubMed)

Other Identifiers

06/NIR03/64

Identifier Type: -

Identifier Source: org_study_id