Effect of Protein Source During Ketogenic Weight Loss Intervention

Condition(s) studied

Investigational drug(s) / intervention(s)

Protein supplement - Plant protein: Pea/lupine protein powder mix

Protein supplement - Animal protein: Whey protein powder

Study 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

Eligibility

Primary outcome measure(s)

• Change in weight — Baseline and at 12 weeks
  Overall weight loss, kg
• 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.
• 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.
• 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.
• 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.
• 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,
• Rate of pre-adipocyte proliferation — Baseline and at 12 weeks
  Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro

Trial sites (1)

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