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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05141526
• Other study ID #: SAT-2-129796
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: October 2023
• Source: Laval University
• Contact: Vicky Drapeau, PhD
• Phone: 4186562131
• Email: vicky.drapeau[@]fse.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Appetite Control
• Body Weight
• Weight Loss
• Weight Maintenance

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Department of Physical Education	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight	Body weight loss (kg) after Phases 1 and 2	6 months
Primary	Body composition	Body fat (using dual x-ray absorptiometry)	6 months
Primary	Hunger/Satiety	using a visual analogue scale and measured in mm	6 months
Primary	Energy intake	measured at an ad libitum meal in kilocalories	6 months
Secondary	Stress	State-Trait Anxiety Inventory	18 months
Secondary	Anxiety	Perceived Stress Scales	18 months
Secondary	Eating Behaviours	Three Factor Eating Behaviour Questionnaire	18 months
Secondary	Depression Symptoms	Beck Depression Inventory	18 months
Secondary	Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)	measured in mmol/L	18 months
Secondary	Blood pressure	mmHg	18 months
Secondary	Diet satisfaction	Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree)	18 months
Secondary	neurobehavioural variables	brain anatomy and activity in response to food cues (using fMRI)	6 months