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This randomized, controlled, single-blinded study will investigate how the protein source in a high-protein ketogenic diet affects metabolic weight loss outcomes after a 12-week dietary intervention
This randomized, controlled, single-blinded study will compare how a ketogenic weight loss diet, supplemented with either animal- or plant-based protein affects: (i) metabolic markers (adipokine and cytokine) in adipose tissue and blood, (ii) adipose tissue immune cell profiles, and (iii) adipocyte characteristics and their interaction with other cells (e.g. immune cells and muscle cells). To better determine how tissue characteristics affect the whole body level, the relationships between adipose tissue characteristics and blood lipid and inflammatory markers will also be examined. Participants undergo anthropometric measurements, questionnaires, body composition assessment, energy assessment, blood draws, and adipose tissue biopsies from the abdominal and femoral adipose tissue depots
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based pea/lupine protein supplement | Experimental |
| |
| Animal-based whey protein supplement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein supplement - Plant protein | Dietary Supplement | Pea/lupine protein powder mix |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Overall weight loss, kg | Baseline and at 12 weeks |
| Change in BMI | Height and weight will be combined to report BMI (kg/m^2) | Baseline and at 12 weeks |
| Change in fat mass | Body composition is measured by dual energy x-ray absorptiometry. | Baseline and at 12 weeks |
| Change in overall body fat percentage | Body composition is measured by dual energy x-ray absorptiometry. | Baseline and at 12 weeks |
| Regional subcutaneous adipose tissue immune cells ( number of cells per gram tissue, percentage of the stromal vascular compartment) | Changes in various adipose tissue immune cells including M1-like and M2-like macrophages, T helper cells, and cytotoxic T cells will be measured via flow cytometry. | Baseline and at 12 weeks |
| Concentrations of Circulatory cytokines and adipokines | Changes in cytokines and adipokines will be measured via ELISA. We will measure markers including interleukin 6, tumour necrosis factor a, leptin, and adiponectin. | Baseline and at 12 weeks |
| Resting energy expenditure | Resting energy expenditure will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the resting energy expenditure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvia Santsa, PhD | Concordia University, Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Health, Concordia University | Montreal | Quebec | H4B 1R6 | Canada |
On request and approval by ethics
The data will be available after the study results have been accepted for publication. The data will be available for 5 y.
On request with ethics approval.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Participant are randomized to a plant or animal protein based ketogenic diet for a 12 week period. They are provided with the plant or animal proteins which they consume in the form of a smoothie twice a day. The remaining meal comprises of self selected foods.
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Participants are provided with unlabelled protein containers in this single-blind study.
| Protein supplement - Animal protein | Dietary Supplement | Whey protein powder |
|
| Baseline and at 12 weeks |
| Substrate oxidation | Substrate oxidation will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the respiratory exchange ratio. | Baseline and at 12 weeks |
| Lipidomics | Lipidomics will be measured by mass spectrometry. | Baseline and at 12 weeks |
| Adipocyte size | Regional adipocyte characteristics will be measured in vitro including adipocyte size, | Baseline and at 12 weeks |
| Rate of pre-adipocyte proliferation | Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro | Baseline and at 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |