NCT01654172

Brief Summary

Cocoa flavanols form part of the family of chemicals (also found in red wine and tea) which have aroused interest due to population studies suggesting that diets high in these substances might reduce risks of heart disease. In the laboratory, these flavanols have been shown to cause blood vessels to widen and blood flow to increase. As dysfunction in this ability of blood vessels to widen is now thought to play a central role in the complications of diabetes, novel ways to mitigate this are constantly being sought. The present study aims to use non-invasive magnetic resonance imaging (MRI) to measure foot and brain blood flow before and after 7 days consumption of a cocoa drink high in flavanols, in subjects with diabetes, with and without peripheral neuropathy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

2.3 years

First QC Date

July 25, 2012

Last Update Submit

July 30, 2012

Conditions

Diabetes

Keywords

Diabetesperipheral neuropathyCocoa flavanols

Outcome Measures

Primary Outcomes (1)

  • Change in Fasting Brain Blood Flow

    Measured by ASL-MR at Day 0 and after 7d consumption of a cocoa drink to detect a change following intervention

    Day 0 and after 7d consumption of a cocoa drink

Secondary Outcomes (6)

  • Change in Brain blood flow after acute consumption of cocoa

    1,3,5 and 8hrs after cocoa consumption

  • Change in Fasting foot blood flow

    Day 0 and after 7d consumption of a cocoa drink

  • Change in Foot blood flow after acute consumption of cocoa

    1,3,5 and 8hrs after cocoa consumption

  • Change in Blood Flavanol concentration

    Day 0 and after 7d consumption of a cocoa drink

  • Change in Fasting oxidative stress status

    Day 0 and after 7 days of consuming a cocoa drink

  • +1 more secondary outcomes

Study Arms (2)

High Flavanol Cocoa

EXPERIMENTAL

Cocoa drink containing \~450mg cocoa flavanols and 10g carbohydrate per serving. Subject consumes 2 servings per day, for 7 days.

Dietary Supplement: High Flavanol Cocoa

Low Flavanol Cocoa

PLACEBO COMPARATOR

Cocoa drink containing \~25mg cocoa flavanols and 10g carbohydrate per serving. Subject consumes 2 servings per day, for 7 days.

Dietary Supplement: Low Flavanol Cocoa

Interventions

High Flavanol CocoaDIETARY_SUPPLEMENT

Total daily flavanol intake provided by the high flavanol drink is \~900mg

High Flavanol Cocoa
Low Flavanol CocoaDIETARY_SUPPLEMENT
Low Flavanol Cocoa

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Peripheral neuropathy or free from neuropathy

You may not qualify if:

  • Current foot ulceration
  • Hypertension
  • Anti-hypertensive medications other than thiazide diuretics and ACE inhibitors
  • Ischaemic heart disease
  • Peripheral vascular disease (ABPI ,0.9 \&/or impalpable foot pulses)
  • Chronic kidney disease
  • Poor glycaemic control
  • DVT
  • Epilepsy
  • Pregnancy
  • Contraindications to MRI
  • Intolerance to lactose or cow's milk protein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Notts, NG72UH, United Kingdom

Location

MeSH Terms

Conditions

Diabetes MellitusPeripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Simon Paige, MD

    University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 31, 2012

Study Start

September 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

GB(1)