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

NCT05141526 | Unknown

• 1 other identifier: SAT-2-129796
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Stress

  18 months

• Anxiety

  18 months

• Eating Behaviours

  18 months

• Depression Symptoms

  18 months

• Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)

  18 months

Study Arms (3)

Non-restrictive satiating intervention

EXPERIMENTAL

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

Conventional restrictive intervention + non-restrictive satiating intervention

EXPERIMENTAL

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

Minimal healthy guidelines

PLACEBO COMPARATOR

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

Interventions

Non-restrictive satiating intervention OTHER

Diet group containing satiating foods

Non-restrictive satiating intervention

Control group OTHER

This group will receive minimal healthy guidelines

Minimal healthy guidelines

Conventional restrictive intervention + non-restrictive satiating intervention OTHER

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

Conventional restrictive intervention + non-restrictive satiating intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laval University: lead
• University of Ottawa: collaborator

Study Sites (1)

Department of Physical Education

Québec, Quebec, G1V0A6, Canada

RECRUITING

MeSH Terms

Conditions

Weight Loss

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Vicky Drapeau, PhD

CONTACT

4186562131; vicky.drapeau@fse.ulaval.ca

Lucie Brunelle, MSc, RD

CONTACT

4186562131; lucie.brunelle@kin.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: (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

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: December 2, 2021
• Study Start: January 15, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2025
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

CA (1)