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Effects of Combining Cocoa and Soy in Type 2 Diabetes

NCT01754662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-07-15

No results posted yet for this study

Summary

Diabetes is an increasingly common condition affecting millions of people world wide. The cornerstone of treatment is lifestyle that includes looking at the way how people eat. It is known that food containing compounds called polyphenols can reduce the risk of heart disease risk in people with diabetes. Two foods that are rich sources of polyphenols are cocoa (epicatechins) and soy (isoflavones). Previous studies have shown the benefits of these foods in the diets of people with diabetes. It has also been shown that soy isoflavones and cocoa polyphenols can improve the mood in certain groups of patients.

What is not known is whether there is any extra benefit of combining soy protein and isoflavones with cocoa.

The aim of the study is to look at the modification of cardiovascular risk by soy and/or cocoa in patients with type 2 diabetes, alone or in combination.

Conditions

Interventions

DIETARY_SUPPLEMENT

Soy protein

2 bars daily for 8 weeks.

DIETARY_SUPPLEMENT

Isoflavones

2 bars daily for 8 weeks.

DIETARY_SUPPLEMENT

Cocoa

2 bars daily for 8 weeks.

DIETARY_SUPPLEMENT

Placebo

Sponsors & Collaborators

  • University of Hull

    collaborator OTHER

  • Hull University Teaching Hospitals NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Stephen Atkin · University of Hull

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01754662 on ClinicalTrials.gov