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Satiating Diet vs. Restrictive Intervention for Obesity

N/A
Recruiting
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged between 18-50 years
Individuals with a BMI ≥30 and <40 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial is evaluating the effect of a non-restrictive, satiating intervention on appetite control, weight loss and maintenance in men and women living with obesity, compared to a conventional restrictive intervention and a control group.

Who is the study for?
This trial is for men and women aged 18-50 with obesity, defined by a waist circumference over 102 cm for men or over 88 cm for women, and a BMI between 30 and <40. Participants should not be on medications affecting weight or appetite, have chronic diseases, use excessive alcohol or caffeine, or be pregnant. They also shouldn't engage in high physical activity.Check my eligibility
What is being tested?
The study tests if a non-restrictive satiating diet helps control appetite and maintain weight loss better than conventional diets. Over 18 months, participants follow either this diet throughout; switch from calorie restriction to the satiating diet; or follow minimal guidelines then recommended maintenance strategies.See study design
What are the potential side effects?
Potential side effects are not specified but may include changes in digestion due to dietary adjustments. As it's focused on dietary interventions rather than medication, severe side effects are unlikely compared to drug trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old.
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My BMI is between 30 and 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body composition
Body weight
Energy intake
+1 more
Secondary outcome measures
Anxiety
Blood pressure
Depression Symptoms
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-restrictive satiating interventionExperimental Treatment1 Intervention
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).
Group II: Conventional restrictive intervention + non-restrictive satiating interventionExperimental Treatment1 Intervention
Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2)
Group III: Minimal healthy guidelinesPlacebo Group1 Intervention
Considering recommendations from the latest Canadian Obesity Guidelines, the control group will receive a minimal intervention based on the Canada's Food Guide for Healthy Eating

Find a Location

Who is running the clinical trial?

Laval UniversityLead Sponsor
417 Previous Clinical Trials
172,038 Total Patients Enrolled
3 Trials studying Weight Loss
153 Patients Enrolled for Weight Loss
University of OttawaOTHER
207 Previous Clinical Trials
266,907 Total Patients Enrolled
4 Trials studying Weight Loss
416 Patients Enrolled for Weight Loss

Media Library

Control group Clinical Trial Eligibility Overview. Trial Name: NCT05141526 — N/A
Weight Loss Research Study Groups: Conventional restrictive intervention + non-restrictive satiating intervention, Minimal healthy guidelines, Non-restrictive satiating intervention
Weight Loss Clinical Trial 2023: Control group Highlights & Side Effects. Trial Name: NCT05141526 — N/A
Control group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05141526 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for new participants to join this research endeavor?

"Affirmative. Clinicaltrials.gov houses data that evidences the need for 234 volunteers at 1 medical centre since its inception on January 15th 2022, and most recently updated August 23rd 2022."

Answered by AI

Am I eligible to become involved in this research endeavor?

"To qualify for this research, individuals should have experienced weight loss and be part of the age bracket between 18 and 50. Approximately 234 participants are needed to complete the requirements of this trial."

Answered by AI

Is eligibility for this clinical trial open to individuals over twenty years of age?

"This medical trial is accepting applicants aged 18 or older, up to a maximum of 50 years old."

Answered by AI

What is the cap for individuals taking part in this research endeavor?

"Affirmative. Clinicaltrials.gov confirms the ongoing recruitment of 234 patients to take part in this medical trial that was first announced on January 15th 2022 and amended most recently on August 23rd 2022 at one specific site."

Answered by AI

What are the chief aims of this clinical experiment?

"This 6-month trial aims to assess changes in hunger and satiety. Secondary objectives include evaluation of anxiety with the Perceived Stress Scale, stress levels measured by State-Trait Anxiety Inventory, as well as lipids (HDL-cholesterol, LDL-cholesterol, triglycerides & total cholesterol) measured in mmol/L."

Answered by AI

Who else is applying?

What site did they apply to?
Department of Physical Education
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried various diets I'm unable to progress with any of those Hence opting for a clinical trial that might work for me.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity
Vicky Drapeau 2022. "Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05141526.
All > Weight Loss
~43 spots leftby Nov 2024
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