NCT04291391

The Alberta NutrIMM Study - Nutrition and Immunity

The Alberta NutrIMM (Nutrition and Immune Function) Study: Establishing the Importance of Diet and Insulin Resistance in Modulating Immune Function in Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	North American-type diet	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)

Timeline

• Start date: 2019-09-01
• Primary completion: 2023-05-16
• Completion: 2023-12-01
• First posted: 2020-03-02
• Last updated: 2024-02-06

Locations

1 site across 1 country: Canada