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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-15

Study Completion Date

2025-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Weight Loss Weight Maintenance Appetite Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

(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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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).

Group Type EXPERIMENTAL

Non-restrictive satiating intervention

Intervention Type OTHER

Diet group containing satiating foods

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)

Group Type EXPERIMENTAL

Conventional restrictive intervention + non-restrictive satiating intervention

Intervention Type OTHER

Diet group with a calorie deficit during the first phase followed by a diet containing satiating foods in the second phase

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

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type OTHER

This group will receive minimal healthy guidelines

Interventions

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Non-restrictive satiating intervention

Diet group containing satiating foods

Intervention Type 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

Intervention Type OTHER

Control group

This group will receive minimal healthy guidelines

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes