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Effect of a dietary intervention on Functional Immune sTatus in the elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN45031464
Enrollment
216
Registered
2007-08-13
Start date
2006-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study looks at immune function in healthy subjects Nutritional, Metabolic, Endocrine Immune function and nutrition

Interventions

Volunteers will be randomised to one of three intervention groups: 1. Dietary intervention: volunteers will be asked to consume a diet aimed at increasing the intake of fruit and vegetables (to five

Sponsors

The University of Sheffield (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women 2. Community based healthy volunteers 3. Aged 65 to 85 years 4. Living an active independent life 5. Low intake of fruit and vegetables (less than or equal to two portions per day)

Exclusion criteria

Exclusion criteria: 1. Hospitalised within past 12 months 2. Current or recent (within three months) users of micronutrient supplements 3. Have a Body Mass Index (BMI) less than 18 or more than 30 4. Have a special diet or about to embark on a weight loss diet 5. Have a malignancy or severe medical or psychiatric illness 6. Cannot understand or communicate effectively 7. Have insulin-dependent diabetes mellitus

Design outcomes

Secondary

MeasureTime frame
1. Dietary intake and dietary change, measured using three-day food diaries 2. Physical activity, measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) physical activity questionnaire 3. Quality of life, measured using the 36-item Geriatric Depression Scale (GDS36) 4. Body composition, measured by body weight, height, triceps skin-fold thickness The primary and secondary outcomes will be measured at baseline, end of intervention and three months post-intervention.

Primary

MeasureTime frame
1. Innate and adaptive immunity, measured using: 1.1. High-Sensitivity C-Reactive Protein (hSCRP) 1.2. Natural killer cell cytotoxicity 1.3. Neutrophil and monocyte oxidative burst and phagocytic activity 1.4. T-cell activation 1.5. Reponse to tetanus vaccine (administered at eight weeks) 2. Nutritional status, measured by: 2.1. Plasma carotenoids 2.2. Retinol 2.3. Vitamin E 2.4. Ascorbic acid 2.5. Selenium 2.6. Glutathione peroxidase 2.7. Zinc 3. Number of days infection, measured using a self-reported infection diary The primary and secondary outcomes will be measured at baseline, end of intervention and three months post-intervention, with the exception of the response to tetanus vaccine which is measured at 8 weeks and 12 weeks only (coinciding with tetanus vaccination and end of intervention).

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026