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North American Diet for Obesity and Type 2 Diabetes (NutrIMM Trial)
N/A
Waitlist Available
Led By Caroline Richard, PhD, RD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
NutrIMM Trial Summary
This trial will help researchers understand how weight, diet, and blood sugar levels affect immune function and heart disease risk.
Who is the study for?
Adults aged 18-70 with stable body weight, fitting specific BMI or waist circumference criteria, and categorized by glucose levels and other health markers can join. Those with dietary restrictions, immune system diseases, untreated thyroid issues, pregnancy intentions during the study period, recent cardiovascular events or cancer survivors within five years are excluded.Check my eligibility
What is being tested?
The Alberta NutrIMM Study is testing how a North American-type diet affects immune function in people with varying levels of obesity and blood sugar control. It's a controlled feeding trial for four weeks where participants are divided into groups based on their obesity status and whether they have normal blood sugar (NG), glucose intolerance (GI), or type 2 diabetes (T2D).See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive discomfort due to new foods or changes in diet composition. However, no specific side effects related to medications are expected as it is not a drug trial.
NutrIMM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Differences between groups in IL-2 Secretion by Peripheral Blood Mononuclear Cells (PBMC) After Ex-vivo Stimulation with Phytohemagglutinin (PHA) at Week 4
Differences between groups in circulating C-reactive protein (CRP) at Week 4
Secondary outcome measures
Change from Baseline in B Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Change from Baseline in Circulating Glucose Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Change from Baseline in Circulating Hemoglobin A1c Levels at Week 4 and Differences Between Groups at Baseline and Week 4
+24 moreOther outcome measures
Assess correlations between clinical outcomes and microbiome to identify interactions and microbiome signatures that predict how diet may impact these indicators in obese, insulin resistant, and diabetic subjects.
Gut microbiota composition by using DNA Sequencing
NutrIMM Trial Design
4Treatment groups
Experimental Treatment
Group I: Individuals without obesity and normoglycemia (NG) (Lean-NG)Experimental Treatment1 Intervention
Those assigned to the Lean-NG group will receive a North American-type diet diet for 4 weeks.
Group II: Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D)Experimental Treatment1 Intervention
Those assigned to the Obese-T2D group will receive a North American-type diet diet for 4 weeks.
Group III: Individuals with obesity and glucose intolerance (GI) (Obese-GI)Experimental Treatment1 Intervention
Those assigned to the Obese-GI group will receive a North American-type diet diet for 4 weeks.
Group IV: Individuals with obesity and NG (Obese-NG)Experimental Treatment1 Intervention
Those assigned to the Obese-NG group will receive a North American-type diet diet for 4 weeks.
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Who is running the clinical trial?
University of AlbertaLead Sponsor
888 Previous Clinical Trials
384,844 Total Patients Enrolled
18 Trials studying Obesity
11,449 Patients Enrolled for Obesity
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,303 Total Patients Enrolled
56 Trials studying Obesity
9,647 Patients Enrolled for Obesity
Caroline Richard, PhD, RDPrincipal InvestigatorUniversity of Alberta
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently adjusting your medication or starting a new treatment, or your HbA1c level is higher than 10.5%.You have a disease that affects your immune system, like an infection, inflammation, or an autoimmune condition.You have a thyroid disease that is not being treated or controlled.You must be between 18 and 70 years old.You have had heart problems recently.You have kidney or hormone problems other than type 2 diabetes.Your glucose, HbA1c, HDL-C, and triglyceride levels must meet certain requirements for you to be placed in a specific group.You have had any type of cancer within the past five years, even if you are in remission.You use cannabis regularly.Your body mass index (BMI) should be within the range of 18.5 to 24.9 or between 30 to 50, or your waist circumference should be less than 88 cm for females and less than 102 cm for males.
Research Study Groups:
This trial has the following groups:- Group 1: Individuals without obesity and normoglycemia (NG) (Lean-NG)
- Group 2: Individuals with obesity and NG (Obese-NG)
- Group 3: Individuals with obesity and glucose intolerance (GI) (Obese-GI)
- Group 4: Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently enrolled in this experiment?
"Affirmative. The information on clinicaltrials.gov implies that this trial is welcoming participants at the moment. This study was first listed on September 1st 2019 and underwent its most recent update on April 5th 2022, expecting 132 individuals to join from a single site."
Answered by AI
What is the eligibility criteria for participating in this clinical experiment?
"This clinical trial has 132 slots available for individuals aged between 18 and 65 that have been diagnosed with type 2 diabetes. Eligibility criteria include fasting blood glucose levels of less than 5.6 mmol/L, an HbA1c level of no more than 10%, a waist circumference in men greater than 102 cm and women greater than 88 cm, systolic pressure/diastolic pressure values lower than 130/85 mmHg respectively, as well as triglyceride levels below 1.7 mmol/L and HDL-C above the recommended threshold for either sex (men: 1.03mmol/L; women:"
Answered by AI
Does this research endeavor include elderly individuals among its participants?
"This trial is open to adults between 18 and 65 years of age. Other clinical trials have been made available for minors (241) as well as seniors (1229)."
Answered by AI
Is there availability for individuals to join this clinical research?
"According to information on clinicaltrials.gov, this study is still recruiting subjects. It was first advertised in September 2019 and the most recent changes were implemented in April 2022."
Answered by AI
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