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

Immune Function Clinical Trial

— ADIT  

Official title:

Effect of Fruit and Vegetable Consumption on Immune Function in the Elderly: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858728
• Other study ID #: 06/NIR03/64
• Status: Completed
• Phase: N/A
• Start date: October 2006
• Est. completion date: September 2009

Study information

• Verified date: December 2021
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Immune Function

Intervention

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 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).

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast	Co Antrim

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University, Belfast

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in natural killer cell cytotoxicity and antibody response to Tetanus toxoid and Pneumovax II vaccination		16 weeks
Secondary	Change in other markers of immune function		16 weeks