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

Laval University

Status: Enrolling

Conditions: Appetite Control; Weight Loss; Weight Maintenance

Treatments: Other: Control group; Other: Non-restrictive satiating intervention; Other: Conventional restrictive intervention + non-restrictive satiating intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05141526

SAT-2-129796

Details and patient eligibility

About

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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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234 participants in 3 patient groups, including a placebo group

Non-restrictive satiating intervention

Experimental group

Description:

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).

Treatment:

Other: Non-restrictive satiating intervention

Conventional restrictive intervention + non-restrictive satiating intervention

Experimental group

Description:

Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2)

Treatment:

Other: Conventional restrictive intervention + non-restrictive satiating intervention

Minimal healthy guidelines

Placebo Comparator group

Description:

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

Treatment:

Other: Control group