Designer Functional Foods on Parameters of Metabolic and Vascular in Prediabetes

NCT02400450 | Withdrawn

• 1 other identifier: B2014:041
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Pre-Diabetes

Keywords

Pre-diabetes; prediabetes; glycated hemoglobin; hemoglobin A1c; LDL cholesterol; Cholesterol; metabolic function; vascular function; functional food

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (11)

• Blood Lipids (Total Cholesterol, HDL-Cholesterol, and Triglycerides)

  12 Weeks

• Blood Glucose

  12 Weeks

• Insulin

  12 Weeks

• C-Reactive Protein

  12 Weeks

• Advanced Glycation End-products (AGE)

  12 Weeks

Study Arms (2)

Functional Ingredient Group

EXPERIMENTAL

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. The food items will contain a standardized amount of functional ingredients.

Dietary Supplement: Functional Ingredient Group

Control Ingredient Group

PLACEBO COMPARATOR

The control group will receive a comparable set of food items that contain an equivalent amount of calories per portion but without the added functional ingredients.

Dietary Supplement: Control Ingredient Group

Interventions

Functional Ingredient Group DIETARY_SUPPLEMENT

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.

Also known as: Step One Foods (TruHealthMD)

Functional Ingredient Group

Control Ingredient Group DIETARY_SUPPLEMENT

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.

Control Ingredient Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the following criteria to be eligible for participation in the study:
• Male, or non-pregnant, non-lactating females, aged 21 - 75 years;
• Glycated hemoglobin A1c ≥6.0% and \<7.0%;
• Body-mass index 18-40;
• Able to read, write and communicate orally in English;
• Willing to maintain a stable level of activity during participation in the study;
• Willing to comply with protocol requirements and procedures;
• Willing to provide written informed consent.

You may not qualify if:

• 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:
• Previous diagnosis of diabetes or taking diabetes medications (glucose-lowering medications, insulin);
• \. 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). \[Note that individuals with hypertension and/or taking anti-hypertensive medication are eligible to participate.\];
• \. Fasting LDL-cholesterol \>160 mg/dL (\>4.1 mmol/L);
• \. Fasting triglycerides \>400 mg/dL (\>4.5 mmol/L);
• \. Serum alanine aminotransferase (ALT) outside the normal range of 7-56 units/L;
• \. Serum creatinine outside the normal range of 0.7-1.3 mg/dL for males and 0.6-1.1 mg/dL for females;
• \. Conditions which affect normal nutrient absorption (e.g. Celiac disease, inflammatory bowel disease);
• \. Untreated endocrine disorders with the potential to affect glucose and lipid metabolism;
• \. 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);
• \. Food allergies or intolerances which severely limit the variety of study food products that can be consumed;
• \. Eating philosophies or eating patterns that would limit or not include consumption of the study foods;
• \. Any acute medical condition or surgical intervention within the past 3 months;
• \. 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;
• \. Currently participating in or having participated in a food intervention study within the last month;

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Science and Technology International Collaboration Fund: collaborator
• Manitoba Agri-Health Research Network: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (16)

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• 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. Epub 2009 Oct 29.

  PMID: 19878986 BACKGROUND

• 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. Epub 2013 Nov 1.

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

  PMID: 23940694 BACKGROUND

• 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. doi: 10.2174/2212798411204010050.

  PMID: 22329631 BACKGROUND

• Lee T, Dugoua JJ. Nutritional supplements and their effect on glucose control. Adv Exp Med Biol. 2012;771:381-95. doi: 10.1007/978-1-4614-5441-0_27.

  PMID: 23393691 BACKGROUND

• 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.

  PMID: 22739611 BACKGROUND

• 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. Epub 2011 Aug 5.

  PMID: 21843614 BACKGROUND

• 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.

  PMID: 22654403 BACKGROUND

• 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.

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• 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. Epub 2012 Jul 14.

  PMID: 22980902 BACKGROUND

• 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.

  PMID: 24499073 BACKGROUND

• 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. No abstract available.

  PMID: 23331432 BACKGROUND

• 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. Epub 2013 Feb 26.

  PMID: 23485142 BACKGROUND

• Welch RW, Antoine JM, Berta JL, Bub A, de Vries J, Guarner F, Hasselwander O, Hendriks H, Jakel 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.

  PMID: 22129662 BACKGROUND

• 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. Epub 2011 Jun 29.

  PMID: 21715526 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State

Condition Hierarchy (Ancestors)

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

Study Officials

• Carla Taylor, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: March 27, 2015
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CA (1); US (1)