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

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: Recruiting
• Conditions: Weight Loss; Weight Maintenance; Appetite Control
• Intervention / Treatment: Other: Non-restrictive satiating intervention; Other: Conventional restrictive intervention + non-restrictive satiating intervention; Other: Control group

• Study Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vicky Drapeau, PhD; Phone Number: 4186562131; Email: vicky.drapeau@fse.ulaval.ca
• Study Contact Backup: Name: Lucie Brunelle, MSc, RD; Phone Number: 4186562131; Email: lucie.brunelle@kin.ulaval.ca

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Body weight	Body weight loss (kg) after Phases 1 and 2	6 months
Body composition	Body fat (using dual x-ray absorptiometry)	6 months
Hunger/Satiety	using a visual analogue scale and measured in mm	6 months
Energy intake	measured at an ad libitum meal in kilocalories	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	State-Trait Anxiety Inventory	18 months
Anxiety	Perceived Stress Scales	18 months
Eating Behaviours	Three Factor Eating Behaviour Questionnaire	18 months
Depression Symptoms	Beck Depression Inventory	18 months
Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)	measured in mmol/L	18 months
Blood pressure	mmHg	18 months
Diet satisfaction	Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree)	18 months
neurobehavioural variables	brain anatomy and activity in response to food cues (using fMRI)	6 months

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: University of Ottawa

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID 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