Effect of Protein Source During Ketogenic Weight Loss Intervention

Obesity Clinical Trial

Official title:

Effect of Protein Source During Ketogenic Weight Loss Intervention on Lipid Metabolism and Inflammation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06461806
• Other study ID #: 90000185
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Concordia University, Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity; Endocrine
• Weight Loss

Intervention

Dietary Supplement:
• Protein supplement - Plant protein
Pea/lupine protein powder mix
• Protein supplement - Animal protein
Whey protein powder

Locations

Country	Name	City	State
Canada	School of Health, Concordia University	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Concordia University, Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Overall weight loss, kg	Baseline and at 12 weeks
Primary	Change in BMI	Height and weight will be combined to report BMI (kg/m^2)	Baseline and at 12 weeks
Primary	Change in fat mass	Body composition is measured by dual energy x-ray absorptiometry.	Baseline and at 12 weeks
Primary	Change in overall body fat percentage	Body composition is measured by dual energy x-ray absorptiometry.	Baseline and at 12 weeks
Primary	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
Primary	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
Primary	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.	Baseline and at 12 weeks
Primary	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
Primary	Lipidomics	Lipidomics will be measured by mass spectrometry.	Baseline and at 12 weeks
Primary	Adipocyte size	Regional adipocyte characteristics will be measured in vitro including adipocyte size,	Baseline and at 12 weeks
Primary	Pre-adipocyte proliferation	Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro	Baseline and at 12 weeks
Primary	Pre-adipocyte differentiation	Regional adipose tissue pre-adipocyte differentiation will be measured in vitro	Baseline and at 12 weeks