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NCT05141526

Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity

Status unknown NA Last updated 5 October 2023
What this trial tests

NA trial testing Non-restrictive satiating intervention in Weight Loss in 234 participants. Status unknown.

Timeline
15 January 2022
Primary endpoint
1 November 2024
1 November 2025

Quick facts

Lead sponsorLaval University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment234
Start date15 January 2022
Primary completion1 November 2024
Estimated completion1 November 2025
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Laval University

Who can join

Adults 18 to 50, any sex, with Weight Loss or Weight Maintenance. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. This is an 18-month, randomized, controlled, parallel weight loss \[Phase 1 (P1): 6 months\] and maintenance trial \[Phase 2 (P2): 12 months\] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). All groups will be controlled for physical activity and sleep patterns. The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Measurements at baseline (week 0), after P1 and P2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. Follow-ups will be done by a dietitian every 2 weeks during P1 and once a month during P2.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Weight Loss

Currently open trials in the same condition.

Other Laval University trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing