CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Soy protein +3 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01754662
NCT01754662N/ACompleted

A Pilot Study Investigating the Effects of the Combined Effects of Cocoa and Soy Polyphenols in a Soy Protein Matrix on Insulin Resistance and Cardiovascular Disease Risk in Type 2 Diabetes - A Randomised Placebo-Controlled Double-Blind Parallel Study

Hull University Teaching Hospitals NHS Trust·interventional·Posted Dec 21, 2012·Updated Jul 15, 2019

In Brief

A clinical study evaluating Soy protein, Isoflavones, and 2 other interventions for Type 2 Diabetes and Dietary Intervention. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
CollaboratorsUniversity of Hull

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2012
Enrollment StartOct 1, 2011
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.5 years ago

Interventions

Soy proteindietary

2 bars daily for 8 weeks.

Isoflavonesdietary

2 bars daily for 8 weeks.

Cocoadietary

2 bars daily for 8 weeks.

Placebodietary