Diet and Vascular Health Study

NCT01114399 | Completed

• 1 other identifier: 2009IFR01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to examine the effects of a diet rich in broccoli on cardiovascular disease risk using biochemical indicators such as blood lipid profiles, most notably cholesterol; markers of inflammation as well as established physiological measurements such as Pulse wave velocity (PWV), Augmentation index (AIx) and Ambulatory Blood Pressure Measurements (ABPM). Broccoli contains compounds known as glucosinolates which are metabolised to isothiocyanates when consumed. The major glucosinolate in broccoli is known as glucoraphanin which produces the isothiocyanate sulforaphane. The glucosinolates are thought to be the principal component in broccoli that may reduce CVD risk. The investigators will use a standard cultivar of broccoli and a cultivar that has enhanced levels of glucosinolates ('HG broccoli'). This broccoli has been used in previous intervention studies (e.g. ClinicalTrials.gov NCT00535977). Volunteers will be asked to consume 400g of standard broccoli, HG broccoli or peas each week over a 12 week period in a double blinded (for the broccoli) parallel study. The volunteers recruited will, according to the Joint British Societies (JBS 2) Guidelines on the prevention of cardiovascular disease (CVD) in clinical practise, have a 10-20% (mild to moderate) risk of developing cardiovascular disease or having a cardiovascular (CV) event in the next 10 years.

Conditions

Cardiovascular Disease

Keywords

Cardiovascular Disease; Cardiovascular Disease risk (mild to moderate); Cholesterol; Ambulatory blood pressure; Arterial Stiffness

Outcome Measures

Primary Outcomes (1)

• Examination of the indicators of CVD after the consumption of broccoli, high glucosinolate broccoli and peas.

  To examine the effects of a diet rich in broccoli on the systemic indicators of CVD including total cholesterol as well as established physiological measurements such as ambulatory blood pressure (BP), Augmentation Index (AIx) and Pulse Wave velocity (PWV) in subjects with a mild to moderate (10-20%) risk of developing CVD within the next 10 years

  Week 12

Secondary Outcomes (1)

• The determination of key polymorphic genes of the trial subjects

  Baseline

Study Arms (3)

Standard Broccoli

EXPERIMENTAL

Standard Broccoli

Dietary Supplement: Diet and Vascular Health

High Glucosinolate Broccoli

EXPERIMENTAL

High Glucosinolate Broccoli

Dietary Supplement: Diet and Vascular Health

Peas

EXPERIMENTAL

Peas

Dietary Supplement: Diet and Vascular Health Study

Interventions

Diet and Vascular Health Study DIETARY_SUPPLEMENT

One group will consume 400g of standard broccoli each week for 12weeks; the second group will consume 400g of the high glucosinolate broccoli each week for 12weeks while the third group will consume 400g of peas each week for 12weeks. The broccoli and the peas will be consumed on top of the volunteer's standard diet.

Peas

Diet and Vascular Health DIETARY_SUPPLEMENT

One group will consume 400g of standard broccoli each week for 12weeks; the second group will consume 400g of the high glucosinolate broccoli each week for 12weeks while the third group will consume 400g of peas each week for 12weeks. The broccoli and the peas will be consumed on top of the volunteer's standard diet.

Standard Broccoli

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged ≥ 50 years will be recruited onto the study using the JBS 2 cardiac risk assessor calculator (Copyright University of Manchester 1998): Scores of 10-20% will be acceptable for participation in the study.
• Total cholesterol ≥ 5.0mmol/L
• Blood pressure measurements
• Systolic≥ 120mmHg
• Diastolic ≥ 80mmHg
• BMI ≥20
• Smokers and Non Smokers

You may not qualify if:

• Diagnosed diabetics;
• Fasting glucose \>6mmol/L;
• Blood pressure \<90/50 or 95/55 if symptomatic; \>160/100
• Chronic kidney disease;
• Those on any lipid lowering therapies like statins, bile acid sequestrants, cholesterol absorption inhibitors and nicotinic acid;
• Those who have suffered a cardiovascular event like stroke, myocardial infarction or trans ischemic attacks;
• Peripheral vascular disease including Claudication
• Consumption of fish oil supplements (unless volunteer is willing to discontinue their use 4 weeks prior to the start of the)
• Parallel participation in another research project which involves dietary intervention and/or sampling of biological fluids/materials
• Any person related or living with any member of the study team
• Participation in another research project which involves blood sampling within the last four months; Blood from both studies should not exceed 470mL
• BMI \<20
• BMI \>40
• Fasting total cholesterol \> 8.0mmol/L
• Gastrointestinal disease (excluding hiatus hernia) unless symptomatic or study intervention/procedure is contraindicated

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator
• University of East Anglia: collaborator

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (1)

• Armah CN, Traka MH, Dainty JR, Defernez M, Janssens A, Leung W, Doleman JF, Potter JF, Mithen RF. A diet rich in high-glucoraphanin broccoli interacts with genotype to reduce discordance in plasma metabolite profiles by modulating mitochondrial function. Am J Clin Nutr. 2013 Sep;98(3):712-22. doi: 10.3945/ajcn.113.065235.

  PMID: 23964055 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Diet

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: May 3, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

GB (1)