Clinical trial NCT06461806: Effect of Protein Source During Ketogenic Weight Loss Intervention
Official title: Effect of Protein Source During Ketogenic Weight Loss Intervention on Lipid Metabolism and Inflammation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Obesity; Endocrine
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Adults between 18-60 years old
* BMI: \>29.99kg/m2

Exclusion Criteria:

* Any chronic metabolic conditions (e.g. CVD)
* Renal impairment (creatinine clearance \<60 mL/min)
* Uncontrolled hypothyroidism
* Pregnant, breastfeeding, or postmenopausal females
* Past (\<6 year) or present use of nicotine products
* Use of cannabis products
* Use of any other medications that may affect study outcomes (e.g. anti-depressants)
* Participants who have had a number of CT scans in the course of the year
* Participants following a vegan diet

Primary outcomes:
measure: Change in weight
timeFrame: Baseline and at 12 weeks
measure: Change in BMI
timeFrame: Baseline and at 12 weeks
measure: Change in fat mass
timeFrame: Baseline and at 12 weeks
measure: Change in overall body fat percentage
timeFrame: Baseline and at 12 weeks
measure: Regional subcutaneous adipose tissue immune cells ( number of cells per gram tissue, percentage of the stromal vascular compartment)
timeFrame: Baseline and at 12 weeks
measure: Concentrations of Circulatory cytokines and adipokines
timeFrame: Baseline and at 12 weeks
measure: Resting energy expenditure
timeFrame: Baseline and at 12 weeks
measure: Substrate oxidation
timeFrame: Baseline and at 12 weeks
measure: Lipidomics
timeFrame: Baseline and at 12 weeks
measure: Adipocyte size
timeFrame: Baseline and at 12 weeks
measure: Rate of pre-adipocyte proliferation
timeFrame: Baseline and at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: School of Health, Concordia University
state: Quebec
Study officials:
affiliation: Concordia University, Montreal
name: Sylvia Santsa, PhD
role: PRINCIPAL_INVESTIGATOR
References: