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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
Must not have
Being treated with insulin for type 2 diabetes
Symptoms of depression (>20 on the BDI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am being treated with insulin for type 2 diabetes.
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I have severe symptoms of depression.
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My weight has changed by more than 4 kg in the last two months.
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I am currently taking sedatives or sleeping pills.
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I am a woman who is either premenopausal, currently menstruating, or pregnant.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body composition
Body weight
Energy intake
+1 more
Secondary study objectives
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
423 Previous Clinical Trials
172,794 Total Patients Enrolled
3 Trials studying Weight Loss
153 Patients Enrolled for Weight Loss
University of OttawaOTHER
213 Previous Clinical Trials
268,038 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
~7 spots leftby Nov 2024
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