Effects of Combining Cocoa and Soy in Type 2 Diabetes

NCT01754662 | Completed

• 1 other identifier: R1188
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Type 2 Diabetes; Dietary Intervention

Keywords

Type 2 diabetes; Cardiovascular risk; Endothelial function; Insulin resistance; Soy; Isoflavones; Cocoa; Diet

Outcome Measures

Primary Outcomes (1)

• Insulin resistance, lipid profile

  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 Outcomes (3)

• Cardiovascular risk

  8 weeks

• Isoflavones

  8 weeks

• Endothelial function

  8 weeks

Study Arms (5)

Soy protein with isoflavones and cocoa

EXPERIMENTAL

Soy protein with isoflavones and cocoa bars. 2 bars daily for 8 weeks.

Dietary Supplement: Soy protein; Dietary Supplement: Isoflavones; Dietary Supplement: Cocoa

Soy protein alone with cocoa

EXPERIMENTAL

Soy protein alone with cocoa with no isoflavones. 2 bars daily for 8 weeks.

Dietary Supplement: Soy protein; Dietary Supplement: Cocoa

Soy protein with soy isoflavones

EXPERIMENTAL

Soy protein with isoflavones bar. 2 bars daily for 8 weeks.

Dietary Supplement: Soy protein; Dietary Supplement: Isoflavones

Soy protein alone

EXPERIMENTAL

Soy protein alone without soy isoflavone or cocoa polyphenol. 2 bars daily for 8 weeks.

Dietary Supplement: Soy protein

Placebo

PLACEBO COMPARATOR

Placebo bar without soy protein, isoflavones or cocoa polyphenols. 2 bars daily for 8 weeks

Dietary Supplement: Placebo

Interventions

Soy protein DIETARY_SUPPLEMENT

2 bars daily for 8 weeks.

Soy protein alone; Soy protein alone with cocoa; Soy protein with isoflavones and cocoa; Soy protein with soy isoflavones

Isoflavones DIETARY_SUPPLEMENT

2 bars daily for 8 weeks.

Soy protein with isoflavones and cocoa; Soy protein with soy isoflavones

Cocoa DIETARY_SUPPLEMENT

2 bars daily for 8 weeks.

Soy protein alone with cocoa; Soy protein with isoflavones and cocoa

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Michael White Diabetes Centre

Hull, North Humberside, HU3 2RW, United Kingdom

Location

Related Publications (13)

• Anderson JW, Smith BM, Washnock CS. Cardiovascular and renal benefits of dry bean and soybean intake. Am J Clin Nutr. 1999 Sep;70(3 Suppl):464S-474S. doi: 10.1093/ajcn/70.3.464s.

  PMID: 10479219 BACKGROUND

• Vedavanam K, Srijayanta S, O'Reilly J, Raman A, Wiseman H. Antioxidant action and potential antidiabetic properties of an isoflavonoid-containing soyabean phytochemical extract (SPE). Phytother Res. 1999 Nov;13(7):601-8. doi: 10.1002/(sici)1099-1573(199911)13:73.0.co;2-o.

  PMID: 10548755 BACKGROUND

• Lee DS, Lee SH. Genistein, a soy isoflavone, is a potent alpha-glucosidase inhibitor. FEBS Lett. 2001 Jul 13;501(1):84-6. doi: 10.1016/s0014-5793(01)02631-x.

  PMID: 11457461 BACKGROUND

• Sorenson RL, Brelje TC, Roth C. Effect of tyrosine kinase inhibitors on islets of Langerhans: evidence for tyrosine kinases in the regulation of insulin secretion. Endocrinology. 1994 Apr;134(4):1975-8. doi: 10.1210/endo.134.4.8137766.

  PMID: 8137766 BACKGROUND

• Wagner JD, Cefalu WT, Anthony MS, Litwak KN, Zhang L, Clarkson TB. Dietary soy protein and estrogen replacement therapy improve cardiovascular risk factors and decrease aortic cholesteryl ester content in ovariectomized cynomolgus monkeys. Metabolism. 1997 Jun;46(6):698-705. doi: 10.1016/s0026-0495(97)90016-0.

  PMID: 9186308 BACKGROUND

• Duncan AM, Underhill KE, Xu X, Lavalleur J, Phipps WR, Kurzer MS. Modest hormonal effects of soy isoflavones in postmenopausal women. J Clin Endocrinol Metab. 1999 Oct;84(10):3479-84. doi: 10.1210/jcem.84.10.6067.

  PMID: 10522983 BACKGROUND

• Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake is associated with cardiovascular disease risk factors in postmenopausal women. J Nutr. 2001 Apr;131(4):1202-6. doi: 10.1093/jn/131.4.1202.

  PMID: 11285326 BACKGROUND

• Hermansen K, Sondergaard M, Hoie L, Carstensen M, Brock B. Beneficial effects of a soy-based dietary supplement on lipid levels and cardiovascular risk markers in type 2 diabetic subjects. Diabetes Care. 2001 Feb;24(2):228-33. doi: 10.2337/diacare.24.2.228.

  PMID: 11213870 BACKGROUND

• Tsai AC, Vinik AI, Lasichak A, Lo GS. Effects of soy polysaccharide on postprandial plasma glucose, insulin, glucagon, pancreatic polypeptide, somatostatin, and triglyceride in obese diabetic patients. Am J Clin Nutr. 1987 Mar;45(3):596-601. doi: 10.1093/ajcn/45.3.596.

  PMID: 2881482 BACKGROUND

• Jayagopal V, Albertazzi P, Kilpatrick ES, Howarth EM, Jennings PE, Hepburn DA, Atkin SL. Beneficial effects of soy phytoestrogen intake in postmenopausal women with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1709-14. doi: 10.2337/diacare.25.10.1709.

  PMID: 12351466 BACKGROUND

• Chedraui P, San Miguel G, Hidalgo L, Morocho N, Ross S. Effect of Trifolium pratense-derived isoflavones on the lipid profile of postmenopausal women with increased body mass index. Gynecol Endocrinol. 2008 Nov;24(11):620-4. doi: 10.1080/09513590802288283.

  PMID: 19031218 BACKGROUND

• Scholey AB, French SJ, Morris PJ, Kennedy DO, Milne AL, Haskell CF. Consumption of cocoa flavanols results in acute improvements in mood and cognitive performance during sustained mental effort. J Psychopharmacol. 2010 Oct;24(10):1505-14. doi: 10.1177/0269881109106923. Epub 2009 Nov 26.

  PMID: 19942640 BACKGROUND

• Konya J, Sathyapalan T, Kilpatrick ES, Atkin SL. The Effects of Soy Protein and Cocoa With or Without Isoflavones on Glycemic Control in Type 2 Diabetes. A Double-Blind, Randomized, Placebo-Controlled Study. Front Endocrinol (Lausanne). 2019 May 9;10:296. doi: 10.3389/fendo.2019.00296. eCollection 2019.

  PMID: 31143160 BACKGROUND

Related Links

• publication link

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Soybean Proteins; Isoflavones; Chocolate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stephen Atkin

  University of Hull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 15, 2019

Record last verified: 2019-07

Locations

GB (1)