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The Alberta NutrIMM Study - Nutrition and Immunity

NCT04291391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-02-06

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University of Alberta

    lead OTHER

Principal Investigators

  • Caroline Richard, PhD, RD · University of Alberta

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-05-16
Completion
2023-12-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291391 on ClinicalTrials.gov