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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

0 / 7Eligibility criteria met