NCT00410722

Brief Summary

To determine if tree nuts (Almonds, Hazelnuts, Pistachios, Peanuts, Macadamia nuts, Pecans, Walnuts and Cashews) improve glycemic control in type 2 diabetes, as assessed by HbA1c and serum fructosamine, and to assess whether these outcomes relate to improvements in cardiovascular health (i.e. plasma lipids and measures of oxidative stress, inflammatory biomarkers and nitric oxide generation). The investigators have found that nuts tend to reduce the glycemic index of bread and have little effect of raising blood glucose on their own. Therefore the investigators believe that they would be ideal foods to displace high glycemic foods from the diet and lower the dietary glycemic load. This will result in improved blood glucose control in type 2 diabetes, with additional benefits on coronary heart disease risk factors due to other effects of nuts.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

January 9, 2013

Status Verified

January 1, 2013

Enrollment Period

2 years

First QC Date

December 12, 2006

Last Update Submit

January 8, 2013

Conditions

Type 2 DiabetesCardiovascular DiseaseDiet Therapy

Keywords

NutritionType 2 Diabetes

Outcome Measures

Primary Outcomes (4)

  • Markers of glycemic control: Fasting serum fructosamine

    From prestudy and week 0, to end of treatment weeks 8, 10, 12

  • Fasting serum HbA1c

    From prestudy and week 0, to end of treatment weeks 8, 10, and 12

  • Fasting glucose

    From prestudy and week 0, to end of treatment and weeks 8, 10, and 12

  • Fasting insulin

    From prestudy and week 0, to end of treatment and weeks 8, 10, and 12

Secondary Outcomes (13)

  • 24h urinary C-peptide excretion

    From prestudy and week 0, to end of treatment weeks 8, 10, and 12

  • Branched chain amino acids

    From prestudy and week 0, to end of treatment weeks 8, 10, and 12

  • Serum triglyceride

    From prestudy and week 0, to end of treatment weeks 8, 10, and 12

  • Very Low-Density Lipoprotein (VLDL) triglyceride

    From prestudy and week 0, to end of treatment weeks 8, 10, and 12

  • VLDL-C

    From prestudy and week 0, to end of treatment weeks 8, 10, and 12

  • +8 more secondary outcomes

Study Arms (3)

Full-Dose Nut

EXPERIMENTAL

Subjects will be given tree nuts (almonds, hazelnuts, pistachios, macadamia nuts, pecans, walnuts, and cashews) and peanuts (at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet.

Dietary Supplement: Mixed tree nuts

Half-Dose Nut

EXPERIMENTAL

Subjects will be given tree nuts (almonds, hazelnuts, pistachios, macadamia nuts, pecans, walnuts, and cashews) and peanuts as well as the control supplement (wheat bran muffin)(at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet.

Dietary Supplement: Whole wheat and bran muffinDietary Supplement: Mixed tree nuts

Control

ACTIVE COMPARATOR

Subjects will be given a control supplement (wheat bran muffin)(at a predetermined amount to consume based on their recommended energy intake), and advised to follow a diabetic diet.

Dietary Supplement: Whole wheat and bran muffin

Interventions

Whole wheat and bran muffinDIETARY_SUPPLEMENT
ControlHalf-Dose Nut
Mixed tree nutsDIETARY_SUPPLEMENT
Full-Dose NutHalf-Dose Nut

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and post menopausal women with type 2 diabetes treated with diet plus oral hypoglycemic agents (sulfonylureas (glyburide), biguanides (metformin), Thiazolidinediones (TZDs) and new secretagogues (Repaglinide)) at a stable dose for at least 3 months prior to starting the study;
  • HbA1c of 6.5 to 8.0% as a compromise between those whose levels are acceptable and the level which is currently considered unacceptable.
  • Diabetes diagnosed \>6 months prior to randomization
  • Weight stable within 3% body weight \>2 months.

You may not qualify if:

  • Use of acarbose
  • Use of Insulin
  • Known nut allergies
  • Clinically significant gastroparesis
  • Use of steroids
  • Presence of GI disease (celiac disease, ulcerative colitis, and Crohns)
  • Major cardiovascular event (stroke or myocardial infarction)
  • Major surgery \< 6 months prior to randomization
  • Presence of major debilitating disorder such as clinically significant liver disease (not including non-alcoholic fatty liver (NAFL) or non-alcoholic steatohepatitis (NASH) but including cirrhosis, infectious hepatitis (B and C), aspartate transaminase (AST) or alanine transaminase (ALT) \> 130 IU/L)
  • Renal failure (high creatinine \> 150 mmol/L)
  • Serum triglyceride \> 6 mmol/L.
  • Patients currently undergoing treatment for cancer with the exception of non-melanoma skin cancer, but not high risk patients or those whose treatment has been successfully completed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (3)

  • Jenkins DJA, Kendall CWC, Lamarche B, Banach MS, Srichaikul K, Vidgen E, Mitchell S, Parker T, Nishi S, Bashyam B, de Souza RJ, Ireland C, Pichika SC, Beyene J, Sievenpiper JL, Josse RG. Nuts as a replacement for carbohydrates in the diabetic diet: a reanalysis of a randomised controlled trial. Diabetologia. 2018 Aug;61(8):1734-1747. doi: 10.1007/s00125-018-4628-9. Epub 2018 May 23.

    PMID: 29789878DERIVED

  • Nishi SK, Kendall CW, Bazinet RP, Bashyam B, Ireland CA, Augustin LS, Blanco Mejia S, Sievenpiper JL, Jenkins DJ. Nut consumption, serum fatty acid profile and estimated coronary heart disease risk in type 2 diabetes. Nutr Metab Cardiovasc Dis. 2014 Aug;24(8):845-52. doi: 10.1016/j.numecd.2014.04.001. Epub 2014 May 13.

    PMID: 24925120DERIVED

  • 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: 21715526DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David JA Jenkins, MD, PhD

    University of Toronto, St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

  • Cyril WC Kendall, PhD

    University of Toronto, St. Michael's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Start

December 1, 2006

Primary Completion

December 1, 2008

Last Updated

January 9, 2013

Record last verified: 2013-01

Locations

CA(1)