Status:
COMPLETED
The Alberta NutrIMM Study - Nutrition and Immunity
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
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 w...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04291391
Start Date
September 1 2019
End Date
December 1 2023
Last Update
February 6 2024
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1