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

Sponsor

Laval University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05141526

Collaborator

University of Ottawa (Other)

234

Enrollment

Arms

45.5

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Weight Maintenance Appetite Control	Other: Non-restrictive satiating intervention Other: Conventional restrictive intervention + non-restrictive satiating intervention Other: Control group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

234 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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(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:

Double (Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 15, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Laval University
University of Ottawa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vicky Drapeau, Principal Investigator, Laval University

ClinicalTrials.gov Identifier:

NCT05141526

Other Study ID Numbers:

SAT-2-129796

First Posted:

Dec 2, 2021

Last Update Posted:

Dec 2, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Body Weight

Weight Loss

Study Results

No Results Posted as of Dec 2, 2021