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Completed

NCT Number: NCT00858728

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

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.

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Key information

Conditions

Immune Function

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University Belfast

Belfast, Co Antrim, BT12 6BJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

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).

Primary outcomes

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

    Time frame: 16 weeks

Secondary outcomes

  1. Change in other markers of immune function

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Registry information

Official study title

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

Acronym: ADIT

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Mar 10, 2009
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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