Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06461806

Effect of Protein Source During Ketogenic Weight Loss Intervention

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Health, Concordia University

Montreal, Quebec, H4B 1R6, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Protein supplement - Plant protein

Dietary Supplement

Pea/lupine protein powder mix

Protein supplement - Animal protein

Dietary Supplement

Whey protein powder

Primary outcomes

  1. Change in weight

    Time frame: Baseline and at 12 weeks

    Overall weight loss, kg

  2. Change in BMI

    Time frame: Baseline and at 12 weeks

    Height and weight will be combined to report BMI (kg/m^2)

  3. Change in fat mass

    Time frame: Baseline and at 12 weeks

    Body composition is measured by dual energy x-ray absorptiometry.

  4. Change in overall body fat percentage

    Time frame: Baseline and at 12 weeks

    Body composition is measured by dual energy x-ray absorptiometry.

  5. Regional subcutaneous adipose tissue immune cells ( number of cells per gram tissue, percentage of the stromal vascular compartment)

    Time frame: 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.

  6. Concentrations of Circulatory cytokines and adipokines

    Time frame: 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.

  7. Resting energy expenditure

    Time frame: 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.

  8. Substrate oxidation

    Time frame: 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.

  9. Lipidomics

    Time frame: Baseline and at 12 weeks

    Lipidomics will be measured by mass spectrometry.

  10. Adipocyte size

    Time frame: Baseline and at 12 weeks

    Regional adipocyte characteristics will be measured in vitro including adipocyte size,

  11. Rate of pre-adipocyte proliferation

    Time frame: Baseline and at 12 weeks

    Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jun 17, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.