Recruiting

Satiating Diet

Sponsor:

Laval University

Code:

NCT05141526

Conditions

Weight Loss

Weight Maintenance

Appetite Control

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Non-restrictive satiating intervention

Conventional restrictive intervention + non-restrictive satiating intervention

Control group

Study Details

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.

Conditions

Weight Loss

Weight Maintenance

Appetite Control

Study ID

NCT05141526

Start date

Jan 15, 2022

Status verified date

Oct, 2023

Completion date

Nov 1, 2025

Anticipated

Primary completion date

Nov 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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 Design

Enrollment

234 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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)

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

Interventions

Non-restrictive satiating intervention

Diet group containing satiating foods

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

Control group

This group will receive minimal healthy guidelines

Primary outcome measure

  • Body weight [ Time Frame: 6 months ]
  • Body composition [ Time Frame: 6 months ]
  • Hunger/Satiety [ Time Frame: 6 months ]
  • Energy intake [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Department of Physical Education

Recruiting

Québec, Quebec, Canada, G1V0A6

More Information

Sponsor

Laval University

Last update posted

Oct 5, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2023-10-05.