Effects of Combining Cocoa and Soy in Type 2 Diabetes

July 11, 2019 updated by: Hull University Teaching Hospitals NHS Trust

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. General information about the study

    The target number of participants is 100. All participants are patients with type 2 diabetes on diet alone or metformin treatment. Participants will be asked to eat two soy bars daily for 8 weeks. The length of the study is 10 weeks and involves 4 visits at the Diabetes Research Centre in Hull, UK.

    The bars will contain:

    • soy protein alone, or
    • soy protein with additional isoflavones, or
    • soy protein with cocoa, or
    • soy protein with isoflavones and cocoa, or
    • placebo bars without soy protein, isoflavones or cocoa.

    The study is randomised (a computer based allocation schema will be used to decide which bars the participant will need to consume). Participants have the same 20% chance to be participant of any of the above groups. The study is placebo-controlled (there is one arm of placebo bars without soy protein, additional isoflavones or cocoa). The study is double-blind (neither the participants or the research team will know which bars they will take).

  2. Study-specific procedures

Visit 1 (week 0). Non-fasting visit. Interested participants discuss the study with a member of the study team who will explain each aspect of the study, following which informed consent will be then obtained. Subsequently, blood pressure, weight, height and waist circumference will be measured, medical history and list of medication are recorded, and blood is taken to determine eligibility. A dietitian will explain about eating a normal diet and the foods we would like the participants to avoid during the study. Vegetarian patients may include too much soy in the diet and for this reason they will not be able to take part in the study. All participants will be non smokers.

Visit 2 (week 2)and Visit 4 (week 10). Fasting visits. Fasting blood is taken and the EndoPAT is performed. Weight, height and waist circumference measurement performed. The EndoPAT test takes between 20-30 minutes. The first box of study bars is dispensed during visit 2. Participants need to consume two bars daily. All remaining uneaten bars and empty wrappers will be collected during visit 4.

Visit 3 (week 6). Non-fasting visit. Height, weight, abdominal circumference, blood pressure are measured. Second box of study bars is dispensed.

Participants are asked to complete a one week food diary and a three day hunger questionnaire before the fasting blood tests. The food diary includes mood rating scales to assess the effect of the consumption of the bars on mood. Participants need to complete these prior to Visit 2 and visit 4.

Participants have 24 hours blood pressure measurement prior to Visit 2 and Visit 4.

24 hours urine collection also takes place prior to visit 2 and visit 4.

3. Optional test incorporated into the study: Body Volume Index measurement Based on participants preference, Body Volume Index measurement is offered as a complementary tool to assess body shape and weight.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • North Humberside
      • Hull, North Humberside, United Kingdom, HU3 2RW
        • Michael White Diabetes Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with type 2 diabetes controlled by diet or metformin only
  • Stable medication history for 3 months prior to screening visit
  • Age 45-80

Exclusion Criteria:

  • Patients with concurrent illness or any medication (especially antibiotics)3 months prior to enrollment that would effect the study results based on investigator's judgement
  • Patients not wishing to allow disclosure to their GPs
  • Pre-menopausal women or on hormone replacement therapy
  • HbA1c >9% at screening
  • Patients with known food allergies
  • Smokers
  • Vegans and vegetarians

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soy protein with isoflavones and cocoa
Soy protein with isoflavones and cocoa bars. 2 bars daily for 8 weeks.
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.
Experimental: Soy protein alone with cocoa
Soy protein alone with cocoa with no isoflavones. 2 bars daily for 8 weeks.
Dietary supplement: Soy protein
2 bars daily for 8 weeks.
Dietary supplement: Cocoa
2 bars daily for 8 weeks.
Experimental: Soy protein with soy isoflavones
Soy protein with isoflavones bar. 2 bars daily for 8 weeks.
Dietary supplement: Soy protein
2 bars daily for 8 weeks.
Dietary supplement: Isoflavones
2 bars daily for 8 weeks.
Experimental: Soy protein alone
Soy protein alone without soy isoflavone or cocoa polyphenol. 2 bars daily for 8 weeks.
Dietary supplement: Soy protein
2 bars daily for 8 weeks.
Placebo Comparator: Placebo
Placebo bar without soy protein, isoflavones or cocoa polyphenols. 2 bars daily for 8 weeks
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin resistance, lipid profile
Time Frame: 8 weeks
Soy with isoflavones and cocoa polyphenols have a greater impact on insulin resistance, lipid parameters in type 2 diabetes than seen with soy protein alone, soy protein with isoflavones and soy protein with cocoa polyphenols.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular risk
Time Frame: 8 weeks
Soy with isoflavones reduces cardiovascular risk as measured by fasting lipids and blood pressure
8 weeks
Isoflavones
Time Frame: 8 weeks
Soy with isoflavones increases plasma isoflavones
8 weeks
Endothelial function
Time Frame: 8 weeks
Soy and cocoa improves endothelial function
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hull University Teaching Hospitals NHS Trust

Collaborators

University of Hull

Investigators

  • Principal Investigator: Stephen Atkin, University of Hull

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 20, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R1188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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