Fruit and vegetable supplement study in obese adults aged 50 years or older

Phase 2

Completed

• Conditions: Obesity; Inflammatory and Immune System - Normal development and function of the immune system; Diet and Nutrition - Obesity

• Registration Number: ACTRN12614000079640
• Lead Sponsor: niversity of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-22
• Study Completion: 2014-12-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Males and females aged >=50 years; obese (BMI >=30kg/m2); absence / irregular menses in females; non-smokers.

Exclusion Criteria

Unwilling or unable to limit intake of fruit and vegetables to no more than 3 serves per day; dietary or nutritional supplement use within the previous 4 weeks; current smokers; chronic excessive alcohol consumption; current participation in a weight management program or actively attempting to lose weight; current use of any medication known to significantly influence inflammation and allergy to fruit or vegetables.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gene expression of inflammatory pathways including NFKB, MAPK & AMPK.<br>Microarray analysis will be used in the discovery phase to identify pathways of interest.<br>Real-time PCR will be performed on genes which demonstrate the greatest fold difference in expressions up to a maximum of 10 genes.<br>[Baseline versus week 8 (end of treatment)]

Secondary Outcome Measures

Name	Time	Method
Plasma cytokines (TNF-a, sTNFR1, sTNFR2, CRP, IL-10) and lipid metabolism/insulin resistance (cholesterol, triglycerides, LDL, HDL, HbA1c, oxidised LDL) will be analysed.<br>Cholesterol, triglycerides, LDL, HDL, HbA1c, oxidised LDL and CRP will measured by the Hunter Area Pathology Service.<br>TNF-a, sTNFR1, sTNFR2, CRP and IL-10 will be measured in our laboratory in plasma using commercial ELISA assay kits.[Baseline versus week 8 (end of treatment)];Arterial stiffness measured by pulse wave velocity using the <br>SphygmoCor Pulse Wave Velocity System SCOR-Vx (AtCor Medical, Sydney, Australia). [Baseline versus week 8 (end of treatment)];Serial Blood pressure measurements (mmHg) using an automatic sphygmomanometer (Welch Allyn 6000 Series). [Baseline versus week 8 (end of treatment)];Plasma antioxidant levels (alpha-carotene, beta-carotene, lutein, lycopene, beta-cryptoxanthin) will be analysed by reverse phase HPLC, using methods established in our laboratory[Baseline versus week 8 (end of treatment)]