Clinical trial

Effect of Protein Source During Ketogenic Weight Loss Intervention

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06461806

Active, not recruitingNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionObesity, Obesity; Endocrine

Full registry criteria

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

Treatments and study arms

Protein supplement - Plant protein

Dietary Supplement

Pea/lupine protein powder mix

Protein supplement - Animal protein

Dietary Supplement

Whey protein powder

Primary outcomes

Change in weightBaseline and at 12 weeks

Overall weight loss, kg

Change in BMIBaseline and at 12 weeks

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

Change in fat massBaseline and at 12 weeks

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

Change in overall body fat percentageBaseline 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 adipokinesBaseline 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 expenditureBaseline 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 oxidationBaseline 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

School of Health, Concordia University🇨🇦 Montreal, Quebec, Canada

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