Effects of Combining Cocoa and Soy in Type 2 Diabetes
Condition: Type 2 Diabetes; Dietary Intervention
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

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.
    

Intervention name(s): Soy protein; Isoflavones; Cocoa; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 bars daily for 8 weeks.; 2 bars daily for 8 weeks.; 2 bars daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Type 2 diabetes; Cardiovascular risk; Endothelial function; Insulin resistance; Soy; Isoflavones; Cocoa; Diet