Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes

Pre-Diabetes Clinical Trial

— PREFFER-2014  

Official title:

Assessment of Designer Functional Foods on Parameters of Metabolic and Vascular Status in Individuals With Prediabetes.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02400450
• Other study ID #: B2014:041
• Status: Withdrawn
• Phase: N/A
• First received: February 11, 2015
• Last updated: February 21, 2017
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-site, double-blind, randomized, controlled food intervention study being conducted at the Canadian Centre for Agri-Food Research in Health and Medicine (CCARM) in Winnipeg and the Mayo Clinic, Rochester, MN, to examine the effects of a portfolio of functional foods on blood glucose and lipids, and blood vessel function in individuals with prediabetes.

A total of 116 participants (n=58/site) with prediabetes (hemoglobin A1c ≥6.0 & <7.0 and no glucose-lowering medications) and body-mass index (BMI) 18-40 will be recruited for a 12-week clinical trial to determine the effect of eating 2 items containing functional ingredients daily compared to 2 similar items lacking the functional ingredients. Study foods provided are to be incorporated into participant's usual diet.

Description:

This study will investigate the effect of a 12 week intervention with a portfolio of 7 food products and 7 comparator products for their effect on glycated hemoglobin, blood lipids, blood vessel function and metabolic parameters in persons with prediabetes. Prediabetes precedes the manifestation of type 2 diabetes and is therefore an appropriate target for dietary interventions. It is also associated with increased cardiovascular disease (CVD) risk because of the presence of abdominal obesity, elevated LDL-cholesterol and reduced vascular function. CVD risk will be assessed based on the profile of lipids and other factors in the blood as well using specialized equipment for non-invasive monitoring of blood vessel function.

If the foods prove beneficial for managing blood glucose levels, the publication of results in scientific journals and in lay documents will increase awareness and provide important information of the health benefits of these products for consumers, health professionals and the food industry. It will also help individuals who may be able to manage their illnesses in a healthful non-pharmaceutical nutritional approach and who may benefit from physician-prescribed nutritional counseling with a focus on foods known to improve certain disease biomarkers. At this time these approaches lack practicality and direct application to individuals who are interested in adopting a new dietary regime capable of disease prevention.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

Participants must meet the following criteria to be eligible for participation in the study:

1. Male, or non-pregnant, non-lactating females, aged 21 - 75 years;

2. Glycated hemoglobin A1c =6.0% and <7.0%;

3. Body-mass index 18-40;

4. Able to read, write and communicate orally in English;

5. Willing to maintain a stable level of activity during participation in the study;

6. Willing to comply with protocol requirements and procedures;

7. Willing to provide written informed consent.

Exclusion Criteria:

Failure to meet any one of the above eligibility criteria will result in an inability to participate in the study. Participants will also be excluded if they have or require any of the following:

1 Previous diagnosis of diabetes or taking diabetes medications (glucose-lowering medications, insulin);

2. Previous diagnosis of cardiovascular disease (e.g. heart attack, stroke, peripheral artery disease), or taking lipid-lowering medications, or having a surgical procedure/intervention to treat cardiovascular disease (e.g. bypass surgery, stent). [Note that individuals with hypertension and/or taking anti-hypertensive medication are eligible to participate.];

3. Fasting LDL-cholesterol >160 mg/dL (>4.1 mmol/L);

4. Fasting triglycerides >400 mg/dL (>4.5 mmol/L);

5. Serum alanine aminotransferase (ALT) outside the normal range of 7-56 units/L;

6. Serum creatinine outside the normal range of 0.7-1.3 mg/dL for males and 0.6-1.1 mg/dL for females;

7. Conditions which affect normal nutrient absorption (e.g. Celiac disease, inflammatory bowel disease);

8. Untreated endocrine disorders with the potential to affect glucose and lipid metabolism;

9. In the previous 3 months and during the study, consumption of supplements or herbals in amounts that lower blood glucose or blood lipids (e.g. chromium, margarine with plant sterols, high fibre supplements such as Metamucil, cinnamon extract, ginseng, bitter melon, gamma-linolenic acid);

10. Food allergies or intolerances which severely limit the variety of study food products that can be consumed;

11. Eating philosophies or eating patterns that would limit or not include consumption of the study foods;

12. Any acute medical condition or surgical intervention within the past 3 months;

13. Conditions or medications which are likely to increase the risk to the participants or study personnel, or to reduce the ability of the participant to comply with the protocol, or affect the results;

14. Currently participating in or having participated in a food intervention study within the last month;

15. Inability to adhere to the study protocol;

16. Unable to obtain blood sample at the screening and/or baseline visit.

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-Diabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Functional Ingredient Group
Participants will be provided with a mix of 6 study products to use over the 12 week trial (2 per day). These will be a) oatmeal, b) pancake mix, c) chocolate crunch bar, d) cranberry nut bar, e) anytime sprinkle, and f) smoothie mix, standardized for the content of functional ingredients.
• Control Ingredient Group
The control group will receive a comparable set of food items to use over the 12 week trial (2 per day). These food items will contain an equivalent amount of calories per portion but without the additional functional ingredients.

Locations

Country	Name	City	State
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Agri-Health Research Network, Manitoba Science and Technology International Collaboration Fund

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (16)

Cheng DM, Kuhn P, Poulev A, Rojo LE, Lila MA, Raskin I. In vivo and in vitro antidiabetic effects of aqueous cinnamon extract and cinnamon polyphenol-enhanced food matrix. Food Chem. 2012 Dec 15;135(4):2994-3002. doi: 10.1016/j.foodchem.2012.06.117. — View Citation

Deng R. A review of the hypoglycemic effects of five commonly used herbal food supplements. Recent Pat Food Nutr Agric. 2012 Apr 1;4(1):50-60. Review. — View Citation

Diabetes Prevention Program Research Group., Knowler WC, Fowler SE, Hamman RF, Christophi CA, Hoffman HJ, Brenneman AT, Brown-Friday JO, Goldberg R, Venditti E, Nathan DM. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009 Nov 14;374(9702):1677-86. doi: 10.1016/S0140-6736(09)61457-4. Erratum in: Lancet. 2009 Dec 19;374(9707):2054. — View Citation

Hlebowicz J, Drake I, Gullberg B, Sonestedt E, Wallström P, Persson M, Nilsson J, Hedblad B, Wirfält E. A high diet quality is associated with lower incidence of cardiovascular events in the Malmö diet and cancer cohort. PLoS One. 2013 Aug 5;8(8):e71095. doi: 10.1371/journal.pone.0071095. — View Citation

Jenkins DJ, Kendall CW, Banach MS, Srichaikul K, Vidgen E, Mitchell S, Parker T, Nishi S, Bashyam B, de Souza R, Ireland C, Josse RG. Nuts as a replacement for carbohydrates in the diabetic diet. Diabetes Care. 2011 Aug;34(8):1706-11. doi: 10.2337/dc11-0338. Retraction in: Diabetes Care. 2016 Feb;39(2):319. — View Citation

Lee T, Dugoua JJ. Nutritional supplements and their effect on glucose control. Adv Exp Med Biol. 2012;771:381-95. Review. — View Citation

Lindström J, Louheranta A, Mannelin M, Rastas M, Salminen V, Eriksson J, Uusitupa M, Tuomilehto J; Finnish Diabetes Prevention Study Group.. The Finnish Diabetes Prevention Study (DPS): Lifestyle intervention and 3-year results on diet and physical activity. Diabetes Care. 2003 Dec;26(12):3230-6. — View Citation

Pawar K, Thompkinson DK. Multiple functional ingredient approach in formulating dietary supplement for management of diabetes: a review. Crit Rev Food Sci Nutr. 2014;54(7):957-73. doi: 10.1080/10408398.2011.621039. Review. — View Citation

Perera PK, Li Y. Functional herbal food ingredients used in type 2 diabetes mellitus. Pharmacogn Rev. 2012 Jan;6(11):37-45. doi: 10.4103/0973-7847.95863. — View Citation

Shane-McWhorter L. Dietary supplements and probiotics for diabetes. Am J Nurs. 2012 Jul;112(7):47-53. doi: 10.1097/01.NAJ.0000415961.92674.d4. — View Citation

Silva FM, Kramer CK, de Almeida JC, Steemburgo T, Gross JL, Azevedo MJ. Fiber intake and glycemic control in patients with type 2 diabetes mellitus: a systematic review with meta-analysis of randomized controlled trials. Nutr Rev. 2013 Dec;71(12):790-801. doi: 10.1111/nure.12076. Review. — View Citation

Stringer DM, Taylor CG, Appah P, Blewett H, Zahradka P. Consumption of buckwheat modulates the post-prandial response of selected gastrointestinal satiety hormones in individuals with type 2 diabetes mellitus. Metabolism. 2013 Jul;62(7):1021-31. doi: 10.1016/j.metabol.2013.01.021. — View Citation

Suksomboon N, Poolsup N, Boonkaew S, Suthisisang CC. Meta-analysis of the effect of herbal supplement on glycemic control in type 2 diabetes. J Ethnopharmacol. 2011 Oct 11;137(3):1328-33. doi: 10.1016/j.jep.2011.07.059. Review. — View Citation

Thondre PS. Food-based ingredients to modulate blood glucose. Adv Food Nutr Res. 2013;70:181-227. doi: 10.1016/B978-0-12-416555-7.00005-9. Review. — View Citation

Vinik AI. A medicinal food provides food for thought in managing diabetic neuropathy. Am J Med. 2013 Feb;126(2):95-6. doi: 10.1016/j.amjmed.2012.08.008. — View Citation

Welch RW, Antoine JM, Berta JL, Bub A, de Vries J, Guarner F, Hasselwander O, Hendriks H, Jäkel M, Koletzko BV, Patterson CC, Richelle M, Skarp M, Theis S, Vidry S, Woodside JV; International Life Sciences Institute Europe Functional Foods Task Force.. Guidelines for the design, conduct and reporting of human intervention studies to evaluate the health benefits of foods. Br J Nutr. 2011 Nov;106 Suppl 2:S3-15. doi: 10.1017/S0007114511003606. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated Hemoglobin (A1c)	Assessments of glycated hemoglobin will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	12 Weeks
Primary	LDL-Cholesterol	Assessments of LDL-Cholesterol will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	12 Weeks
Secondary	Blood Lipids (Total Cholesterol, HDL-Cholesterol, and Triglycerides)	Assessment of blood lipid profile will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	12 Weeks
Secondary	Blood Glucose	Assessment of glucose will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	12 Weeks
Secondary	Insulin	Assessment of insulin (and calculation of insulin sensitivity using HOMA-IR, QUICKI) will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	12 Weeks
Secondary	C-Reactive Protein	Assessment of C-Reactive Protein will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	12 Weeks
Secondary	Advanced Glycation End-products (AGE)	Assessment of advanced glycated endproducts (AGEs) using a non-invasive skin fluorescence device (AGE Reader from Diagnotipics Inc.) will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	12 Weeks
Secondary	Pulse Wave Analysis/Velocity (Blood Vessel Function)	Assessment of blood vessel function (arterial compliance) via pulse-wave analysis and pulse wave velocity will be performed at the Baseline Visit (Day 1), Week 6 (Day 56) and Week 12 (Day 84) visits.	12 Weeks
Secondary	Biomarkers of Vascular Function	Assessment of biomarkers of vascular function in acquired blood samples will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	12 Weeks
Secondary	Biomarkers of Inflammation, Oxidative Stress, Immune Function and Metabolism	Assessment of inflammation, oxidative stress, immune function and metabolism from acquired blood samples will be completed at Baseline Visit (Day 1), Week 6 (Day 42) and Week 12 visits (Day 84) visits.	Week 12
Secondary	Changes in composite measure of Anthropometrics	Changes in anthropometrics, specifically weight, body mass index, waist and hip circumference will be compared to the Baseline Visit (Day 1) and will be acquired at the Week 6 (Day 56) and Week 12 (Day 84) visits. Changes in body fat composition as assessed via dual-energy x-ray absorptiometry (DEXA)) will be assesed at the Baseline Visit (Day 1) and Week 12 (Day 84) visit.	12 Weeks
Secondary	Blood Pressure	Blood pressure will be measure and assessed for changes at the Baseline (Day 1), Week 6 (Day 56) and Week 12 (Day 84) visit.	12 Weeks
Secondary	Food Consumption Patterns	Food consumption patterns will be assessed from Baseline Visit (Day 1) to Week 12 (Day 84) using a questionnaire.	12 Weeks

External Links

•   Canadian Centre for Agri-Food Research in Health and Medicine