Diabetes Mellitus, Type 2NutrIMMNCT04291391
The Alberta NutrIMM Study - Nutrition and Immunity
A study testing North American-type diet in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Alberta at 1 site in Canada.
Trial summary
This study will investigate the effect of body weight, diet, and high blood sugar levels, under controlled feeding conditions, on immune function in individuals with and without obesity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- North American-type diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 1 Dec 2023
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 years to 70 years;
- Body weight stable (± 3%) for at least three months prior to study commencement;
- Body mass index (1) between 18.5 and 24.9 (± 0.5) kg/m2 or (2) between 30 and 50 kg/m2 (± 0.5) kg/m2 or waist circumference >88 cm or > 102 cm for females and males, respectively;
- See below for specific group allocation criteria based on glucose, HbA1c, High density lipoprotein cholesterol (HDL-C), and triglycerides.
- Fasting blood glucose levels (mmol/L): < 5.6 (Lean-NG and Obese-NG), 5.6-6.9 (Obese-GI), and ≥ 7.0 (Obese-T2D);
- HbA1c (%): < 5.5 (Lean-NG and Obese-NG), 5.5-6.4 (Obese-GI), and ≥ 6.5 (Obese-T2D);
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- Blood Pressure (mmHg): < 130/85 (Lean-NG and Obese-NG), not required for Obese-GI and Obese-T2D;
- Triglycerides (mmol/L): < 1.7 (Lean-NG and Obese-NG), not required for Obese-GI and Obese-T2D;
- HDL-C (mmol/L): ≥ 1.03 for males and ≥ 1.29 for females (Lean-NG and Obese-NG), not required for Obese-GI and Obese-T2D.
Who cannot join
- Current or recent history cardiovascular diseases or events (e.g., ischemic, rheumatic, or congenital heart disease, stroke, peripheral vascular disease, heart failure, familial hypercholesterolemia or other monogenic dyslipidemia), use of cardiac implantable electronic devices;
- Current or recent cancer, including remission, during the last five years;
- Diseases known to affect the immune system, such as infectious, inflammatory, and autoimmune diseases or autoimmune-related or suspected conditions (e.g., T1D, systemic lupus erythematosus, inflammatory bowel disease), except for psoriasis, atopic dermatitis, and rheumatoid arthritis. Continuous use of anti-inflammatory or immunosuppressant drugs and supplements for which washout is not possible, except for medications which participants with obesity could not refrain from (e.g., baby aspirins);
- Renal disorders, endocrine disorders other than T2D (e.g., acromegaly, Addison's disease, Cushing's disease);
- Untreated or uncontrolled thyroid diseases (e.g., Hashimoto's disease, hypothyroidism, hyperthyroidism);
- Known allergy, aversion to any components of the menu, or restricted dietary patterns (e.g., gluten-free diet, vegetarianism, kosher or halal diets) for which accommodations within the menu are not possible;
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- Participants under titration of their medication or initiating a new treatment or HbA1c >10.5%;
- Women who are pregnant or plan to become pregnant during the study duration, who are lactating, who have an irregular menstrual cycle or are in perimenopause;
- Regular use of cannabis (e.g. smoking);
- Taking part in any other intervention study that might affect the outcomes of the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Alberta NutrIMM (Nutrition and Immune Function) Study: Establishing the Importance of Diet and Insulin Resistance in Modulating Immune Function in Obesity
This study will investigate the effect of body weight, diet, and high blood sugar levels, under controlled feeding conditions, on immune function in individuals with and without obesity.
This study will be a non-randomized, four-arm parallel group, clinical trial under controlled feeding conditions (4-week nutritional intervention using a North American-type diet). A sample size of n=128 participants will be allocated into one of the following groups:
Read more
- Individuals without obesity and normoglycemia (NG) (Lean-NG)
- Individuals with obesity and normoglycemia (Obese-NG)
- Individuals with obesity and glucose intolerance (GI) (Obese-GI)
- Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D)
The following outcomes will be analyzed:
- Immune cell function (ex-vivo cytokine production after stimulation with mitogen and T cell proliferation);
- Immune cell phenotypes;
- Systemic inflammation (C-reactive protein and plasma cytokines);
- Glucose, insulin, glycated hemoglobin (HbA1c), and lipids;
- Fatty acids and phospholipds composition in plasma and red blood cells membrane.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- North American-type diet
- Keywords
- inflammation, diabetes, obesity, lean
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Inflammation, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
North American-type dietOther
All groups will receive an isocaloric diet for 4 weeks composed of 48% of energy as carbohydrate, 17% as protein, and 35% as lipid (12.5% of saturated fat, 13% of monounsaturated fat, and 6% of polyunsaturated fat), designed to reflect as closely as possible current macronutrient intake averages in North America/Canada.America/Canada (35% of energy as fat, 12.5% as saturated fat, 13% as monounsaturated fat, 6% as polyunsaturated fat, 48% as carbohydrate, 17% as protein)
| Study group | Role | What they receive |
|---|---|---|
| Individuals without obesity and normoglycemia (NG) (Lean-NG) | Experimental | Those assigned to the Lean-NG group will receive a North American-type diet diet for 4 weeks. Receives: Other: North American-type diet |
| Individuals with obesity and NG (Obese-NG) | Experimental | Those assigned to the Obese-NG group will receive a North American-type diet diet for 4 weeks. Receives: Other: North American-type diet |
| Individuals with obesity and glucose intolerance (GI) (Obese-GI) | Experimental | Those assigned to the Obese-GI group will receive a North American-type diet diet for 4 weeks. Receives: Other: North American-type diet |
| Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D) | Experimental | Those assigned to the Obese-T2D group will receive a North American-type diet diet for 4 weeks. Receives: Other: North American-type diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between groups in IL-2 Secretion by Peripheral Blood Mononuclear Cells (PBMC) After Ex-vivo Stimulation with Phytohemagglutinin (PHA) at Week 4
PBMCs will be stimulated with PHA for 48h and IL-2 will be quantified using enzyme-linked immunosorbent assay (ELISA).
Measured: Week 4
Differences between groups in circulating C-reactive protein (CRP) at Week 4
CRP will be measured by Alberta Precision Labs using an immunoturbidimetric assay
Measured: Week 4
Secondary outcomes (27)
Change from Baseline in IL-2 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
PBMCs will be stimulated with Pokeweed Mitogen (PWM) and Phorbol Myristate Acetate and Ionomycin (PMAi), for 48h and IL-2 will be quantified using ELISA
Measured: Baseline and Week 4
Change from Baseline in IL-1B Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
PBMCs will be stimulated with Lipopolysaccharides (LPS) and PWM for 48h and PBMCs will be stimulated with PHA, LPS, PWM, and PMAi for 48h and IFN-y will be quantified using ELISA
Measured: Baseline and Week 4
Change from Baseline in IFN-y Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
PBMCs will be stimulated with PHA, LPS, PWM, and PMAi for 48h and IFN-y will be quantified using ELISA
Measured: Baseline and Week 4
Change from Baseline in TNF-a Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4.
PBMCs will be stimulated with PHA, LPS, PWM, and PMAi for 48h and TNF-a will be quantified using ELISA
Measured: Baseline and Week 4
Change from Baseline in IL-10 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
PBMCs will be stimulated with PHA, LPS, PWM, and PMAi for 48h and IL-10 will be quantified using ELISA
Measured: Baseline and Week 4
Change from Baseline in IL-6 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
PBMCs will be stimulated with PHA, LPS, PWM, PMAi for 48h and IL-6 will be quantified using ELISA
Measured: Baseline and Week 4
Change from Baseline in T cell proliferation at Week 4 and Differences Between Groups at Baseline and Week 4
PBMCs will be stimulated with anti-CD3/anti-CD28 for 72h and proliferation will be quantified using alamarBlue dye method, which is a reliable and sensitive assay
Measured: Baseline and Week 4
Change from Baseline in T Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Immune cell phenotype of T cells will be determined using immunofluorescence staining for flow cytometry. The following monoclonal antibodies will be used: CD3, CD4, CD8, CD25, CD28, CD45RA, CD45RO, CTLA-4 (CD152), CD192, FoxP3, CD183, CD194, CCR10, CD196, and CD185. Data visualization will be performed in FlowJo software
Measured: Baseline and Week 4
Change from Baseline in B Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Immune cell phenotype of B cells will be determined using immunofluorescence staining for flow cytometry. The following monoclonal antibodies will be used: CD19, CD20, ICAM-1 (CD54), CD80, and CD192. Data visualization will be performed in FlowJo software.
Measured: Baseline and Week 4
Change from Baseline in Dendritic Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Immune cell phenotype of dendritic cells will be determined using immunofluorescence staining for flow cytometry. The following monoclonal antibodies will be used: CD11c, CD80, CD213, CD273, and HLA-DR. Data visualization will be performed in FlowJo software
Measured: Baseline and Week 4
Change from Baseline in Natural Killer Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Immune cell phenotype of T cells will be determined using immunofluorescence staining for flow cytometry. The following monoclonal antibodies will be used: CD3, CD16, and CD56. Data visualization will be performed in FlowJo software
Measured: Baseline and Week 4
Change from Baseline in Monocytes at Week 4 and Differences Between Groups at Baseline and Week 4
Immune cell phenotype of Monocytes will be determined using immunofluorescence staining for flow cytometry. The following monoclonal antibodies will be used: CD11c, CD14, ICAM-1 (CD54), CD80, CD86, CD273, and HLA-DR. Data visualization will be performed in FlowJo software
Measured: Baseline and Week 4
Change from Baseline in IL-6 Concentrations at Week 4 and Differences Between Groups at Baseline and Week 4.
IL-6 will be quantified using a multiplex assay (mesoscale).
Measured: Baseline and Week 4
Change from Baseline in TNF-a Concentrations at Week 4 and Differences Between Groups at Baseline and Week 4.
TNF-a will be quantified using a multiplex assay (mesoscale).
Measured: Baseline and Week 4
Change from Baseline in Complete Blood Cell Count and Differential at Week 4 and Differences Between Groups at Baseline and Week 4
Blood count and differential will be analyzed by Alberta Precision Labs in whole blood by fluorescent flow cytometry using a semi-conductor laser and hydrodynamic focusing in dedicated channels using an automated hematology analyzer
Measured: Baseline and Week 4
Change from Baseline in Circulating Glucose Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Glucose will be measured by Alberta Precision Labs with an UV testing using an enzymatic reference method with hexokinase
Measured: Baseline and Week 4
Change from Baseline in Circulating Insulin Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Insulin will be measured by Alberta Precision Labs using an electrochemiluminescence immunoassay
Measured: Baseline and Week 4
Change from Baseline in Circulating Hemoglobin A1c Levels at Week 4 and Differences Between Groups at Baseline and Week 4
HbA1c will be measured by Alberta Precision Labs using a turbidimetric inhibition immunoassay for hemolyzed whole blood
Measured: Baseline and Week 4
Change from Baseline in Circulating Triglycerides Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Triglycerides will be measured by Alberta Precision Labs using an enzymatic colorimetric assay
Measured: Baseline and Week 4
Change from Baseline in Circulating Total Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Total Cholesterol will be measured by Alberta Precision Labs using an enzymatic colorimetric assay
Measured: Baseline and Week 4
Change from Baseline in Circulating Low-Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4
LDL-C is calculated using the following equation: [Total cholesterol - HDLc - (Triglycerides/2.2)]
Measured: Baseline and Week 4
Change from Baseline in Circulating High-Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4
High-Density Lipoprotein Cholesterol will be measured by Alberta Precision Labs using an enzymatic colorimetric assay
Measured: Baseline and Week 4
Change from Baseline in Circulating Non-High Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Non-HDL c is derived from the calculation of total cholesterol minus HDL-c
Measured: Baseline and Week 4
Differences Between Groups at Week 4 in Circulating Glucose Levels before and after an Oral Glucose Tolerance Test
Blood will be collected at the following time points after consuming the glucose solution: 0, 30, 60, 90, 120, 150, and 180 minutes. Plasma glucose concentrations will be measured using the hexokinase/glucose-6-phosphate dehydrogenase method using a clinical chemistry analyzer
Measured: Week 4
Change from Baseline in Total Lipids Fatty Acids Composition in Plasma and Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Proportion of fatty acids will be determined using gas chromatography
Measured: Baseline and Week 4
Change from Baseline in Phospholipids Fatty Acids Composition in Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4.
Proportion of fatty acids from phospholipids will be determined using gas chromatography
Measured: Baseline and Week 4
Change from Baseline in Phospholipids Classes Quantifications in Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4.
Quantification of phospholipds will be determined by high performance liquid chromatography
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Sep 2019
- Primary completion16 May 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 4-parallel arm study
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Caroline Richard, PhD, RD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291391
- Sponsor's protocol ID
- Pro00085839
- Acronym
- NutrIMM
- Status last verified
- Feb 2024
- First submitted
- 29 Nov 2019
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braga Tibaes JR, Barreto Silva MI, Azarcoya-Barrera J, Blanco Cervantes P, Makarowski A, Mereu L, Richard C. Assessment of immune function in individuals without and with obesity and normoglycemia, glucose intolerance, or type 2 diabetes: primary findings of the NutrIMM study, a single-arm controlled feeding trial. Am J Clin Nutr. 2025 Jun;121(6):1315-1327. doi: 10.1016/j.ajcnut.2025.03.003. Epub 2025 Apr 22.
PubMed 40467164Braga Tibaes JR, Barreto Silva MI, Makarowski A, Cervantes PB, Richard C. The nutrition and immunity (nutrIMM) study: protocol for a non-randomized, four-arm parallel-group, controlled feeding trial investigating immune function in obesity and type 2 diabetes. Front Nutr. 2023 Sep 1;10:1243359. doi: 10.3389/fnut.2023.1243359. eCollection 2023.
PubMed 37727636
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alberta NutrIMM (Nutrition and Immune Function) Study: Establishing the Importance of Diet and Insulin Resistance in Modulating Immune Function in Obesity
- ClinicalTrials.gov ID
- NCT04291391
- Acronym / sponsor ID
- NutrIMM / Pro00085839
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- inflammation, diabetes, obesity, lean
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effect of body weight, diet, and high blood sugar levels, under controlled feeding conditions, on immune function in individuals with and without obesity.
This study will be a non-randomized, four-arm parallel group, clinical trial under controlled feeding conditions (4-week nutritional intervention using a North American-type diet). A sample size of n=128 participants will be allocated into one of the following groups:
- Individuals without obesity and normoglycemia (NG) (Lean-NG)
- Individuals with obesity and normoglycemia (Obese-NG)
- Individuals with obesity and glucose intolerance (GI) (Obese-GI)
- Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D)
The following outcomes will be analyzed:
- Immune cell function (ex-vivo cytokine production after stimulation with mitogen and T cell proliferation);
- Immune cell phenotypes;
- Systemic inflammation (C-reactive protein and plasma cytokines);
- Glucose, insulin, glycated hemoglobin (HbA1c), and lipids;
- Fatty acids and phospholipds composition in plasma and red blood cells membrane.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4-parallel arm study
| Arm | Type | Receives |
|---|---|---|
| Individuals without obesity and normoglycemia (NG) (Lean-NG) | Experimental | Other: North American-type dietThose assigned to the Lean-NG group will receive a North American-type diet diet for 4 weeks. |
| Individuals with obesity and NG (Obese-NG) | Experimental | Other: North American-type dietThose assigned to the Obese-NG group will receive a North American-type diet diet for 4 weeks. |
| Individuals with obesity and glucose intolerance (GI) (Obese-GI) | Experimental | Other: North American-type dietThose assigned to the Obese-GI group will receive a North American-type diet diet for 4 weeks. |
| Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D) | Experimental | Other: North American-type dietThose assigned to the Obese-T2D group will receive a North American-type diet diet for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 18 years to 70 years;
- Body weight stable (± 3%) for at least three months prior to study commencement;
- Body mass index (1) between 18.5 and 24.9 (± 0.5) kg/m2 or (2) between 30 and 50 kg/m2 (± 0.5) kg/m2 or waist circumference >88 cm or > 102 cm for females and males, respectively;
- See below for specific group allocation criteria based on glucose, HbA1c, High density lipoprotein cholesterol (HDL-C), and triglycerides.
- Fasting blood glucose levels (mmol/L): < 5.6 (Lean-NG and Obese-NG), 5.6-6.9 (Obese-GI), and ≥ 7.0 (Obese-T2D);
Key exclusion criteria (10 listed)
- Current or recent history cardiovascular diseases or events (e.g., ischemic, rheumatic, or congenital heart disease, stroke, peripheral vascular disease, heart failure, familial hypercholesterolemia or other monogenic dyslipidemia), use of cardiac implantable electronic devices;
- Current or recent cancer, including remission, during the last five years;
- Diseases known to affect the immune system, such as infectious, inflammatory, and autoimmune diseases or autoimmune-related or suspected conditions (e.g., T1D, systemic lupus erythematosus, inflammatory bowel disease), except for psoriasis, atopic dermatitis, and rheumatoid arthritis. Continuous use of anti-inflammatory or immunosuppressant drugs and supplements for which washout is not possible, except for medications which participants with obesity could not refrain from (e.g., baby aspirins);
- Renal disorders, endocrine disorders other than T2D (e.g., acromegaly, Addison's disease, Cushing's disease);
- Untreated or uncontrolled thyroid diseases (e.g., Hashimoto's disease, hypothyroidism, hyperthyroidism);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| North American-type dietAll groups will receive an isocaloric diet for 4 weeks composed of 48% of energy as carbohydrate, 17% as protein, and 35% as lipid (12.5% of saturated fat, 13% of monounsaturated fat, and 6% of polyunsaturated fat), designed to reflect as closely as possible current macronutrient intake averages in North America/Canada.America/Canada (35% of energy as fat, 12.5% as saturated fat, 13% as monounsaturated fat, 6% as polyunsaturated fat, 48% as carbohydrate, 17% as protein) | Other | Individuals with obesity and NG (Obese-NG), Individuals with obesity and glucose intolerance (GI) (Obese-GI), Individuals with obesity and type 2 diabetes (T2D) (Obese-T2D), Individuals without obesity and normoglycemia (NG) (Lean-NG) |
Primary outcome
Differences between groups in IL-2 Secretion by Peripheral Blood Mononuclear Cells (PBMC) After Ex-vivo Stimulation with Phytohemagglutinin (PHA) at Week 4
Time frame: Week 4
PBMCs will be stimulated with PHA for 48h and IL-2 will be quantified using enzyme-linked immunosorbent assay (ELISA).
Differences between groups in circulating C-reactive protein (CRP) at Week 4
Time frame: Week 4
CRP will be measured by Alberta Precision Labs using an immunoturbidimetric assay
27 secondary outcomes
Change from Baseline in IL-2 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in IL-1B Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in IFN-y Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in TNF-a Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4.
Time frame: Baseline and Week 4
Change from Baseline in IL-10 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in IL-6 Secretion by PBMC After Ex-vivo Stimulation with mitogens at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in T cell proliferation at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in T Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in B Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Dendritic Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Natural Killer Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Monocytes at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in IL-6 Concentrations at Week 4 and Differences Between Groups at Baseline and Week 4.
Time frame: Baseline and Week 4
Change from Baseline in TNF-a Concentrations at Week 4 and Differences Between Groups at Baseline and Week 4.
Time frame: Baseline and Week 4
Change from Baseline in Complete Blood Cell Count and Differential at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Circulating Glucose Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Circulating Insulin Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Circulating Hemoglobin A1c Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Circulating Triglycerides Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Circulating Total Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Circulating Low-Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Circulating High-Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Circulating Non-High Density Lipoprotein Cholesterol Levels at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Differences Between Groups at Week 4 in Circulating Glucose Levels before and after an Oral Glucose Tolerance Test
Time frame: Week 4
Change from Baseline in Total Lipids Fatty Acids Composition in Plasma and Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4
Time frame: Baseline and Week 4
Change from Baseline in Phospholipids Fatty Acids Composition in Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4.
Time frame: Baseline and Week 4
Change from Baseline in Phospholipids Classes Quantifications in Red Blood Cells at Week 4 and Differences Between Groups at Baseline and Week 4.
Time frame: Baseline and Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 40467164Braga Tibaes JR, Barreto Silva MI, Azarcoya-Barrera J, Blanco Cervantes P, Makarowski A, Mereu L, Richard C. Assessment of immune function in individuals without and with obesity and normoglycemia, glucose intolerance, or type 2 diabetes: primary findings of the NutrIMM study, a single-arm controlled feeding trial. Am J Clin Nutr. 2025 Jun;121(6):1315-1327. doi: 10.1016/j.ajcnut.2025.03.003. Epub 2025 Apr 22.
- Derived from this study: PubMed 37727636Braga Tibaes JR, Barreto Silva MI, Makarowski A, Cervantes PB, Richard C. The nutrition and immunity (nutrIMM) study: protocol for a non-randomized, four-arm parallel-group, controlled feeding trial investigating immune function in obesity and type 2 diabetes. Front Nutr. 2023 Sep 1;10:1243359. doi: 10.3389/fnut.2023.1243359. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Richard, PhD, RD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing North American-type diet in people with Diabetes Mellitus, Type 2 and Obesity, run by University of Alberta 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 6 Feb 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences between groups in IL-2 Secretion by Peripheral Blood Mononuclear Cells (PBMC) After Ex-vivo Stimulation with Phytohemagglutinin (PHA) at Week 4 (time frame: Week 4). The study lists 2 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 NCT04291391, which also lists 2 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 6 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.