Effect of Protein Source During Ketogenic Weight Loss Intervention

Not Applicable

Active, not recruiting

• Conditions: Obesity; Endocrine; Obesity
• Interventions: Dietary Supplement: Protein supplement - Plant protein; Dietary Supplement: Protein supplement - Animal protein

• Registration Number: NCT06461806
• Lead Sponsor: Concordia University, Montreal

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

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2024-03
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-17
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08
• Primary Completion: 2024-07-31
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plant-based pea/lupine protein supplement	Protein supplement - Plant protein	-
Animal-based whey protein supplement	Protein supplement - Animal protein	-

Primary Outcome Measures

Name	Time	Method
Substrate oxidation	Baseline and at 12 weeks	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.
Lipidomics	Baseline and at 12 weeks	Lipidomics will be measured by mass spectrometry.
Adipocyte size	Baseline and at 12 weeks	Regional adipocyte characteristics will be measured in vitro including adipocyte size,
Change in weight	Baseline and at 12 weeks	Overall weight loss, kg
Change in overall body fat percentage	Baseline and at 12 weeks	Body composition is measured by dual energy x-ray absorptiometry.
Regional subcutaneous adipose tissue immune cells ( number of cells per gram tissue, percentage of the stromal vascular compartment)	Baseline and at 12 weeks	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.
Resting energy expenditure	Baseline and at 12 weeks	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.
Change in BMI	Baseline and at 12 weeks	Height and weight will be combined to report BMI (kg/m\^2)
Change in fat mass	Baseline and at 12 weeks	Body composition is measured by dual energy x-ray absorptiometry.
Concentrations of Circulatory cytokines and adipokines	Baseline and at 12 weeks	Changes in cytokines and adipokines will be measured via ELISA. We will measure markers including interleukin 6, tumour necrosis factor a, leptin, and adiponectin.
Rate of pre-adipocyte proliferation	Baseline and at 12 weeks	Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro

Trial Locations

Locations (1)

School of Health, Concordia University; 🇨🇦 Montréal, Quebec, Canada