Effect of Protein Source During Ketogenic Weight Loss Intervention

NCT06461806 | Active Not Recruiting

• 1 other identifier: 90000185
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Obesity; Endocrine

Outcome Measures

Primary Outcomes (11)

• 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.

  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

Study Arms (2)

Plant-based pea/lupine protein supplement

EXPERIMENTAL

Dietary Supplement: Protein supplement - Plant protein

Animal-based whey protein supplement

EXPERIMENTAL

Dietary Supplement: Protein supplement - Animal protein

Interventions

Protein supplement - Plant protein DIETARY_SUPPLEMENT

Pea/lupine protein powder mix

Plant-based pea/lupine protein supplement

Protein supplement - Animal protein DIETARY_SUPPLEMENT

Whey protein powder

Animal-based whey protein supplement

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Concordia University, Montreal: lead

Study Sites (1)

School of Health, Concordia University

Montreal, Quebec, H4B 1R6, Canada

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sylvia Santsa, PhD

  Concordia University, Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are provided with unlabelled protein containers in this single-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 17, 2024
• Study Start: October 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: January 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after the study results have been accepted for publication. The data will be available for 5 y.
• Access Criteria: On request with ethics approval.

Locations

CA (1)