234 Participants Needed

Satiating Diet vs. Restrictive Intervention for Obesity

VD
LB
Overseen ByLucie Brunelle, MSc, RD

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking medications that could affect your appetite or body weight, such as thyroid replacement therapy, sulfonylureas, or glucocorticoids, you will not be eligible to participate in this trial.

Is the Satiating Diet vs. Restrictive Intervention for Obesity safe for humans?

The research does not provide specific safety data for the Satiating Diet vs. Restrictive Intervention for Obesity, but it discusses various dietary interventions for weight loss, which are generally considered safe when monitored by healthcare professionals.12345

How does the non-restrictive satiating diet treatment for obesity differ from other treatments?

The non-restrictive satiating diet is unique because it allows individuals to eat freely without strict calorie limits, focusing on a balance of higher protein and fat intake to enhance feelings of fullness, which may lead to better adherence and weight loss compared to traditional restrictive diets.678910

What data supports the effectiveness of the treatment Satiating Diet vs. Restrictive Intervention for Obesity?

Research shows that a non-restrictive satiating diet can lead to significant weight loss and improved eating behaviors in obese individuals, with lower dropout rates compared to a control diet. Additionally, personalized dietary strategies that focus on behavior change and energy intake reduction are effective for sustainable weight management.7891112

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-50 with obesity, defined by a waist circumference over 102 cm for men or over 88 cm for women, and a BMI between 30 and <40. Participants should not be on medications affecting weight or appetite, have chronic diseases, use excessive alcohol or caffeine, or be pregnant. They also shouldn't engage in high physical activity.

Inclusion Criteria

Waist circumference >102 cm in men and >88 cm in women
My BMI is between 30 and 40.

Exclusion Criteria

I am being treated with insulin for type 2 diabetes.
I have severe symptoms of depression.
Smoking, drugs or alcohol (>2 drinks/d)
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weight Loss Phase

Participants undergo a 6-month weight loss intervention with different strategies: non-restrictive satiating intervention, conventional restrictive intervention, or minimal healthy guidelines.

6 months
Bi-weekly visits with a dietitian

Maintenance Phase

Participants continue with a 12-month weight maintenance intervention, either continuing the non-restrictive satiating intervention or switching from a restrictive intervention.

12 months
Monthly visits with a dietitian

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Control group
  • Conventional restrictive intervention + non-restrictive satiating intervention
  • Non-restrictive satiating intervention
Trial Overview The study tests if a non-restrictive satiating diet helps control appetite and maintain weight loss better than conventional diets. Over 18 months, participants follow either this diet throughout; switch from calorie restriction to the satiating diet; or follow minimal guidelines then recommended maintenance strategies.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Non-restrictive satiating interventionExperimental Treatment1 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 II: Conventional restrictive intervention + non-restrictive satiating interventionExperimental Treatment1 Intervention
Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2)
Group III: Minimal healthy guidelinesPlacebo Group1 Intervention
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials
439
Recruited
178,000+

University of Ottawa

Collaborator

Trials
231
Recruited
267,000+

Published Research Related to This Trial

In a study of 80 individuals over 24 weeks, those on an energy-restricted diet lost more than twice the weight compared to those on a fat-restricted diet (11.5 kg vs. 5.2 kg).
Participants on the energy-restricted diet also reported better improvements in eating behaviors and feelings of wellness, suggesting that energy restriction may be a more effective and sustainable approach to weight loss than simply reducing dietary fat.
The efficacy of dietary fat vs. total energy restriction for weight loss.Harvey-Berino, J.[2019]
A study involving 69 obese men showed that a non-restrictive satiating diet led to greater fat mass loss and improved adherence compared to a control diet, with only 8.6% dropout in the satiating group versus 44.1% in the control group.
Participants with a high satiety phenotype (HSP) lost more weight than those with a low satiety phenotype (LSP) on the satiating diet, indicating that individual differences in satiety efficiency can influence weight loss outcomes.
Impact of a non-restrictive satiating diet on anthropometrics, satiety responsiveness and eating behaviour traits in obese men displaying a high or a low satiety phenotype.Arguin, H., Tremblay, A., Blundell, JE., et al.[2017]
In a study assessing adherence to a time-restricted eating (TRE) protocol over 5 weeks, actual adherence was around 63% based on continuous glucose monitoring, while participants self-reported an average adherence of about 61%.
Participants identified barriers to following the TRE protocol, such as work schedules and social events, suggesting that personalized TRE plans could enhance adherence and improve health outcomes.
Exploring Rates of Adherence and Barriers to Time-Restricted Eating.Jefcoate, PW., Robertson, MD., Ogden, J., et al.[2023]

Citations

The efficacy of dietary fat vs. total energy restriction for weight loss. [2019]
Impact of a non-restrictive satiating diet on anthropometrics, satiety responsiveness and eating behaviour traits in obese men displaying a high or a low satiety phenotype. [2017]
Exploring Rates of Adherence and Barriers to Time-Restricted Eating. [2023]
The Effectiveness of Nutritional Strategies in the Treatment and Management of Obesity: A Systematic Review. [2023]
Randomized evaluation of a low fat ad libitum carbohydrate diet for weight reduction. [2014]
The effect of time of eating on cardiometabolic risk in primary and secondary prevention of cardiovascular disease. [2023]
Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. [2021]
Dietary treatments of obesity. [2019]
Calorie restriction is more effective for obesity treatment than dietary fat restriction. [2018]
Mindful eating for weight loss in women with obesity: a randomised controlled trial. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Feasibility and outcomes from using a commitment device and text message reminders to increase adherence to time-restricted eating: A randomized trial. [2023]
Assessing the three types of dieting in the Three-Factor Model of dieting. The Dieting and Weight History Questionnaire. [2022]
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