NNTV: NSA Nutritional supplementation Trial of fruit and vegetable extracts and Vascular function

Nutritional Supplementation study of fruit and vegetable extracts and vascular function: a randomised controlled trial of the effects of supplementation with fruit and vegetable extracts on vascular and endothelial function

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14315618

Enrollment

Registered

2014-02-27

Start date

2013-06-03

Completion date

Unknown

Last updated

2021-05-24

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

Conditions

Vascular Function/Cardiovascular Prevention Circulatory System

Interventions

Eighty participants will be randomly assigned to one of two interventions with 40 participants in each intervention group: 1. Standard '5-A-Day' dietary advice and three fruit and veg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 27/10/2014: Eighty, free-living, overweight and obese male and female adults deemed eligible for inclusion in this study. The inclusion criteria are: 1. BMI 25-35 kg/m² 2. Aged 25 - 65 years 3. Non-smoker 4. Willing and able to comply with the study procedures 5. No history of cardiovascular disease (CVD) Previous inclusion criteria: Eighty, free-living, overweight and obese male and female adults deemed eligible for inclusion in this study. The inclusion criteria are: 1. BMI 25-35 kg/m² 2. Aged 25 - 60 years 3. Non-smoker 4. Willing and able to comply with the study procedures 5. No history of cardiovascular disease (CVD)

Exclusion criteria

Exclusion criteria: 1. Smokers 2. History of CVD

Design outcomes

Primary

Measure	Time frame
Change in Carotid Intimal Media Thickness (cIMT) between baseline and 12 weeks of intervention	—

Secondary

Measure	Time frame
1. Dynamic macrovascular changes: flow mediated dilatation, pulse wave analysis (Augmentation Index) and ambulatory blood pressure. 2. Dynamic microvascular changes: laser Doppler imaging following iontopheresis of acetylcholine and sodium nitroprusside. 3. Changes in laboratory blood markers including endothelial cell function and oxidative stress: isoprostanes, selectins and oxidised LDL (as markers of chronic low grade inflammation and vascular dysfunction); fasting insulin and C-peptide (markers of metabolic health); lipids, glucose and HbA1C (classical risk markers). 4. Changes in Knowledge, Attitudes and Practices (KAP): ?5-A-Day? KAP measured using scores from the ?FACET? validated questionnaire to assess FV intake, and related lifestyle measures. 5. Changes to safety monitoring indicators: liver function, full blood count and ECG. The secondary outcome measures are elicited in tandem with the primary outcomes at baseline (test visit 1) and 12 weeks (test visit 2).	—

Measure

Time frame

1. Dynamic macrovascular changes: flow mediated dilatation, pulse wave analysis (Augmentation Index) and ambulatory blood pressure. 2. Dynamic microvascular changes: laser Doppler imaging following iontopheresis of acetylcholine and sodium nitroprusside. 3. Changes in laboratory blood markers including endothelial cell function and oxidative stress: isoprostanes, selectins and oxidised LDL (as markers of chronic low grade inflammation and vascular dysfunction); fasting insulin and C-peptide (markers of metabolic health); lipids, glucose and HbA1C (classical risk markers). 4. Changes in Knowledge, Attitudes and Practices (KAP): ?5-A-Day? KAP measured using scores from the ?FACET? validated questionnaire to assess FV intake, and related lifestyle measures. 5. Changes to safety monitoring indicators: liver function, full blood count and ECG. The secondary outcome measures are elicited in tandem with the primary outcomes at baseline (test visit 1) and 12 weeks (test visit 2).

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026