AzTrials
AzTrials

Type 2 DiabetesPhase 2NCT00410722

Effect of Nuts vs. a Wheat Bran Muffin in Type 2 Diabetes

A Phase 2 study testing Whole wheat and bran muffin and Mixed tree nuts in people with Type 2 Diabetes and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Whole wheat and bran muffin and Mixed tree nuts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteCanada
Study dates
Dec 2006to Dec 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • St. Michael's Hospital

    Toronto, Ontario, M5C 2T2

Other trials in Canada

About this study

Official title: Effect of Nuts on Glycemic Control and Cardiovascular Disease Risk in Type 2 Diabetes

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.

Read the detailed description

The investigators wish to study the effect of nuts on glycemic control and to confirm their lipid lowering effects in type 2 diabetes. The consumption of nuts with their high unsaturated fat, vegetable protein (arginine) and fiber contents will decrease the glycemic load of the diet and improve glycemic control. The investigators anticipate that the favorable fatty acid profile of nuts along with the vegetable protein will improve the blood lipid profile in type 2 diabetes and thereby establish a cardiovascular risk reduction associated with nuts in this population.

Furthermore, flavonoids and vitamin E present in high concentrations in nuts, and known to have antioxidant activity may help to counter the elevated oxidative stress and inflammation experienced by diabetics. The investigators will therefore determine the effect of nut feeding on measures of oxidative stress (including oxidized low-density lipoprotein cholesterol (LDL-C), considered to be of direct relevance to coronary heart disease), inflammation (C-reactive protein, serum amyloid A and interleukin-6) and nitric oxide metabolism (blood nitric oxide and nitrotyrosine levels). These data would further add to interest in nuts in relation to cardiovascular disease risk reduction and diabetic complications.

Background Diet: A diet conforming to the American Diabetes Association (ADA) and National Cholesterol Education Program (NCEP) Adult Treatment Panel III guidelines. Nuts, soy and dietary supplements (vitamins, minerals, herbal remedies) will be excluded in the background diet during all phases of the study.

Treatment diets:(1) Full-Dose Nut Diet: Raw nuts will be added as supplements to the subject's usual diet. Subjects with calorie needs of 2,400 kcal or greater, assessed by Lipid Research Clinic (LRC) tables, will receive the full-dose supplement (100 g/d of nuts, approximately 600 kcal). Subjects requiring between 1,600-2,400 kcal daily will receive 75% of the full-dose supplement (75 g/d of nuts, approximately 450 kcal). Subjects requiring less than 1,600 kcal daily will receive 50% of the full-dose supplement (50 g/d of nuts, approximately 300 kcal). (2) Half-Dose Nut Diet: Raw nuts will be added as supplements to the subject's usual diet. Subjects with calorie needs of 2,400 kcal or greater, assessed by LRC tables, will receive half of the full dose of the nut supplement (50 g/d of nuts, approximately 300 kcal) with the rest of the calories provided by the muffin (2 muffins are 300 kcal) for a total of 600 kcal. Subjects requiring between 1,600-2,400 kcal daily will receive 75% of the half-dose supplement (37.5 g/d of nuts and 1.5 muffins, approximately 450 kcal). Subjects requiring less than 1,600 kcal daily will receive 50% of the half-dose supplement (25 g/d of nuts and 1 muffin, approximately 300 kcal). (3): The full-dose control supplement will be four 150 kcal muffins. Control supplements will be matched with the energy content of the nut supplements, i.e. either 600 kcal/d (4 muffins); 450 kcal/d (3 muffins); 300 kcal/d (2 muffins). The macronutrient composition of the muffins will conform to an NCEP Step 2 diet with 25% total fat, <7% saturated fat by use of corn oil as the oil commonly used in healthy baked goods, with 18% protein (the average for our subject population) using added skim milk powder, and zero cholesterol. Muffins will be made with whole wheat flour.

Diet History: one-week weighed diet histories will be obtained prior to the start and at weeks 4, 8 and 12 of the study for assessment of macronutrients, dietary fiber and fatty acids.

Palatability/Satiety: for palatability and satiety, subjects will record their ratings using a 7-point bipolar semantic scale at monthly intervals during each study phase.

Anthropometry and Blood Pressure: height at recruitment and body weight, blood pressure, waist and hip circumference, and body composition will be taken immediately prior to and at each clinic visit (wk 0, 2, 4, 8, 10, 12) during the study.

Being tested
Whole wheat and bran muffin, Mixed tree nuts
Keywords
Nutrition, Type 2 Diabetes
Medical subject headings
Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole wheat and bran muffinDietary supplement

  • Mixed tree nutsDietary supplement

Study groups in NCT00410722
Study groupRoleWhat they receive
Full-Dose NutExperimentalSubjects 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.
Receives: Dietary Supplement: Mixed tree nuts
Half-Dose NutExperimentalSubjects 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.
Receives: Dietary Supplement: Whole wheat and bran muffin; Dietary Supplement: Mixed tree nuts
ControlActive comparatorSubjects 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.
Receives: Dietary Supplement: Whole wheat and bran muffin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Markers of glycemic control: Fasting serum fructosamine

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

  2. Fasting serum HbA1c

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

  3. Fasting glucose

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

  4. Fasting insulin

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

Secondary outcomes (13)
  1. 24h urinary C-peptide excretion

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

  2. Branched chain amino acids

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

  3. Serum triglyceride

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

  4. Very Low-Density Lipoprotein (VLDL) triglyceride

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

  5. VLDL-C

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

  6. LDL:HDL-C

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

  7. Apolipoprotein B:A1

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

  8. Lipoprotein(a)

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

  9. oxidized LDL

    Measured: From beginning of study, week 0, to end of treatment week 12

  10. markers of oxidative stress

    Measured: From beginning of study, week 0, to end of treatment week 12

  11. C-reactive protein

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

  12. markers of inflammation

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

  13. Cancer cell proliferation

    Measured: From beginning of study, week 0, to end of treatment week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00410722
Sponsor's protocol ID
REB 06-274
Status last verified
Jan 2013
First submitted
12 Dec 2006
Last updated
9 Jan 2013
Results posted
No

Publications

  • 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.

    PubMed 29789878
  • 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.

    PubMed 24925120
  • 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.

    PubMed 21715526

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Whole wheat and bran muffin and Mixed tree nuts in people with Type 2 Diabetes and Cardiovascular Disease, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Markers of glycemic control: Fasting serum fructosamine (time frame: From prestudy and week 0, to end of treatment weeks 8, 10, 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00410722, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in