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

October 3, 2023 updated by: Vicky Drapeau, Laval University

Non-restrictive Approach to Facilitate Appetite Control and Long-term Body Weight Loss in Individuals With Obesity: Can we do Better?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
234

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V0A6
        • Recruiting
        • Department of Physical Education
        • Contact:
          • Lucie Brunelle, Msc, RD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • individuals with a BMI ≥30 and <40 kg/m2
  • aged between 18-50 years
  • waist circumference >102 cm in men and >88 cm in women.

Exclusion Criteria:

  • taking medications that could influence appetite or body weight (e.g. thyroid replacement therapy, sulfonylureas and glucocorticoids)
  • being treated with insulin for type 2 diabetes
  • large body weight fluctuations (>4 kg over last two months)
  • characterized by high restraint behaviour (score >12, measured with the TFEQ)
  • history of an eating disorder (e.g. binge eating disorder) using the EDE questionnaire
  • performing >150 min of moderate-vigorous intensity physical activity/week
  • use of nutritional supplements (multivitamins, calcium, protein, fibre); 8) smoking, drugs or alcohol (>2 drinks/d)
  • consumption of >5 cups of coffee/d
  • (pre)menopausal or pregnant women
  • diagnosis of chronic diseases, acute infections or gastric problems (e.g. ulcers)
  • food allergies/intolerances to ingredients/foods in the satiating intervention
  • having a pacemaker (for fMRI)
  • taking sedatives or sleeping pills
  • symptoms of depression (>20 on the BDI).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Non-restrictive satiating 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).
Other: Non-restrictive satiating intervention
Diet group containing satiating foods
Experimental: Conventional restrictive intervention + non-restrictive satiating intervention
Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2)
Other: Conventional restrictive intervention + non-restrictive satiating intervention
Diet group with a calorie deficit during the first phase followed by a diet containing satiating foods in the second phase
Placebo Comparator: Minimal healthy guidelines
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
Other: Control group
This group will receive minimal healthy guidelines

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body weight
Time Frame: 6 months
Body weight loss (kg) after Phases 1 and 2
6 months
Body composition
Time Frame: 6 months
Body fat (using dual x-ray absorptiometry)
6 months
Hunger/Satiety
Time Frame: 6 months
using a visual analogue scale and measured in mm
6 months
Energy intake
Time Frame: 6 months
measured at an ad libitum meal in kilocalories
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: 18 months
State-Trait Anxiety Inventory
18 months
Anxiety
Time Frame: 18 months
Perceived Stress Scales
18 months
Eating Behaviours
Time Frame: 18 months
Three Factor Eating Behaviour Questionnaire
18 months
Depression Symptoms
Time Frame: 18 months
Beck Depression Inventory
18 months
Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)
Time Frame: 18 months
measured in mmol/L
18 months
Blood pressure
Time Frame: 18 months
mmHg
18 months
Diet satisfaction
Time Frame: 18 months
Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree)
18 months
neurobehavioural variables
Time Frame: 6 months
brain anatomy and activity in response to food cues (using fMRI)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laval University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Ottawa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAT-2-129796

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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