The Alberta NutrIMM Study - Nutrition and Immunity

NCT04291391 | Completed

• 1 other identifier: Pro00085839
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetes Mellitus, Type 2; Obesity

Keywords

inflammation; diabetes; obesity; lean

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  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

  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

  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

  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.

  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

  Baseline and Week 4

Study Arms (4)

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.

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.

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.

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.

Other: North American-type diet

Interventions

North American-type diet OTHER

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)

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)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (2)

• 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.

  PMID: 40467164 DERIVED

• Braga 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.

  PMID: 37727636 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Inflammation; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Caroline Richard, PhD, RD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4-parallel arm study

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: March 2, 2020
• Study Start: September 1, 2019
• Primary Completion: May 16, 2023
• Study Completion: December 1, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)