Effect of Protein Source During Ketogenic Weight Loss Intervention

Concordia University, Montreal

Status: Active, not recruiting

Conditions: Obesity; Endocrine; Obesity

Treatments: Dietary Supplement: Protein supplement - Animal protein; Dietary Supplement: Protein supplement - Plant protein

Study type: Interventional

Funder types: Other

Identifiers

NCT06461806

90000185

Details and patient eligibility

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Plant-based pea/lupine protein supplement

Experimental group

Treatment:

Dietary Supplement: Protein supplement - Plant protein

Animal-based whey protein supplement

Experimental group

Treatment:

Dietary Supplement: Protein supplement - Animal protein