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

Primary Purpose

Weight Loss, Weight Maintenance, Appetite Control

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Non-restrictive satiating intervention
Conventional restrictive intervention + non-restrictive satiating intervention
Control group
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Department of Physical EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Non-restrictive satiating intervention

Conventional restrictive intervention + non-restrictive satiating intervention

Minimal healthy guidelines

Arm Description

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).

Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2)

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

Outcomes

Primary Outcome Measures

Body weight
Body weight loss (kg) after Phases 1 and 2
Body composition
Body fat (using dual x-ray absorptiometry)
Hunger/Satiety
using a visual analogue scale and measured in mm
Energy intake
measured at an ad libitum meal in kilocalories

Secondary Outcome Measures

Stress
State-Trait Anxiety Inventory
Anxiety
Perceived Stress Scales
Eating Behaviours
Three Factor Eating Behaviour Questionnaire
Depression Symptoms
Beck Depression Inventory
Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)
measured in mmol/L
Blood pressure
mmHg
Diet satisfaction
Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree)
neurobehavioural variables
brain anatomy and activity in response to food cues (using fMRI)

Full Information

First Posted
September 20, 2021
Last Updated
October 3, 2023
Sponsor
Laval University
Collaborators
University of Ottawa
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1. Study Identification

Unique Protocol Identification Number
NCT05141526
Brief Title
Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity
Official Title
Non-restrictive Approach to Facilitate Appetite Control and Long-term Body Weight Loss in Individuals With Obesity: Can we do Better?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
University of Ottawa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Weight Maintenance, Appetite Control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
(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). *P1=phase 1; P2=phase 2
Masking
InvestigatorOutcomes Assessor
Masking Description
Blinding participants is not possible due to the nature of the interventions. Individuals independent from the study and blinded to groups (e.g. statistician), will conduct the randomization and analyses while a research assistant, instructed not to discuss treatments with participants, will conduct the testing sessions.
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-restrictive satiating intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional restrictive intervention + non-restrictive satiating intervention
Arm Type
Experimental
Arm Description
Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2)
Arm Title
Minimal healthy guidelines
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Non-restrictive satiating intervention
Intervention Description
Diet group containing satiating foods
Intervention Type
Other
Intervention Name(s)
Conventional restrictive intervention + non-restrictive satiating intervention
Intervention Description
Diet group with a calorie deficit during the first phase followed by a diet containing satiating foods in the second phase
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
This group will receive minimal healthy guidelines
Primary Outcome Measure Information:
Title
Body weight
Description
Body weight loss (kg) after Phases 1 and 2
Time Frame
6 months
Title
Body composition
Description
Body fat (using dual x-ray absorptiometry)
Time Frame
6 months
Title
Hunger/Satiety
Description
using a visual analogue scale and measured in mm
Time Frame
6 months
Title
Energy intake
Description
measured at an ad libitum meal in kilocalories
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Stress
Description
State-Trait Anxiety Inventory
Time Frame
18 months
Title
Anxiety
Description
Perceived Stress Scales
Time Frame
18 months
Title
Eating Behaviours
Description
Three Factor Eating Behaviour Questionnaire
Time Frame
18 months
Title
Depression Symptoms
Description
Beck Depression Inventory
Time Frame
18 months
Title
Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)
Description
measured in mmol/L
Time Frame
18 months
Title
Blood pressure
Description
mmHg
Time Frame
18 months
Title
Diet satisfaction
Description
Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree)
Time Frame
18 months
Title
neurobehavioural variables
Description
brain anatomy and activity in response to food cues (using fMRI)
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
The research questions will take into account sex and gender as we consider: (i) restrictive and non-restrictive approaches that may have different impacts on body weight between men and women; and (ii) the impact of these interventions may have different outcomes on behavioural and psychosocial variables. Therefore, participants may be able to indicate their gender identity.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicky Drapeau, PhD
Phone
4186562131
Email
vicky.drapeau@fse.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie Brunelle, MSc, RD
Phone
4186562131
Email
lucie.brunelle@kin.ulaval.ca
Facility Information:
Facility Name
Department of Physical Education
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V0A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie Brunelle, Msc, RD

12. IPD Sharing Statement

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

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