Effect of Protein Source During Ketogenic Weight Loss Intervention

NCT ID: NCT06461806

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-01-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Obesity Obesity; Endocrine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants are provided with unlabelled protein containers in this single-blind study.

Study Groups

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Plant-based pea/lupine protein supplement

Group Type EXPERIMENTAL

Protein supplement - Plant protein

Intervention Type DIETARY_SUPPLEMENT

Pea/lupine protein powder mix

Animal-based whey protein supplement

Group Type EXPERIMENTAL

Protein supplement - Animal protein

Intervention Type DIETARY_SUPPLEMENT

Whey protein powder

Interventions

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Protein supplement - Plant protein

Pea/lupine protein powder mix

Intervention Type DIETARY_SUPPLEMENT

Protein supplement - Animal protein

Whey protein powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Concordia University, Montreal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvia Santsa, PhD

Role: PRINCIPAL_INVESTIGATOR

Concordia University, Montreal

Locations

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School of Health, Concordia University

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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90000185

Identifier Type: -

Identifier Source: org_study_id

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