Satiating Diet vs. Restrictive Intervention for Obesity

Overseen By Lucie Brunelle, MSc, RD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Thyroid therapy, Sulfonylureas, Glucocorticoids, Insulin

Disqualifiers: Eating disorders, Chronic diseases, Depression, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different approaches to weight loss and maintenance for individuals with obesity. It compares a non-restrictive diet designed to promote fullness with a traditional calorie-cutting diet. The goal is to determine which method better controls appetite and supports long-term weight maintenance. Participants should have a BMI (body mass index) of 30 or more, a waist circumference over 102 cm for men or 88 cm for women, and should not be taking medications that affect weight. The trial lasts 18 months and includes regular follow-ups with a dietitian. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance weight management strategies for many.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the non-restrictive satiating diet and the conventional restrictive diet are generally well-tolerated by participants. Studies have found that the non-restrictive satiating diet helps people adhere to the plan and reduces body fat without causing major health problems. Participants reported feeling fuller for longer, which helped them avoid overeating.

In contrast, the conventional restrictive diet effectively aids weight loss. However, some people find it difficult to maintain over time.

Current research considers both diets safe. Studies have not reported major health issues for either diet. Overall, these diets appear safe for people with obesity, although individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing a satiating diet against restrictive interventions for obesity because it offers a fresh approach to weight management. Unlike traditional calorie-restrictive diets, which often focus on reducing calorie intake by a set amount, the non-restrictive satiating intervention emphasizes the consumption of meals that are not only filling but also low in energy density and glycemic index. This approach incorporates foods high in protein, healthy fats, and essential nutrients, leveraging the natural satiating properties of ingredients like capsaicin found in spices. By potentially enhancing satiety and maintaining nutritional balance without strict calorie limits, this method might offer a more sustainable and enjoyable path to weight loss.

What evidence suggests that this trial's treatments could be effective for obesity?

This trial will compare a conventional restrictive intervention with a non-restrictive satiating intervention for obesity. Research has shown that traditional diets, which involve cutting calories, can lead to moderate weight loss. Studies have found that these diets can help people lose about 5% of their body weight, and a 15-week program might result in losing around 11 kg, with many maintaining the weight loss. Participants in this trial may receive this type of intervention.

In contrast, the non-restrictive satiating intervention, another option in this trial, focuses on filling meals that are low in calories but rich in nutrients like protein and healthy fats. This diet has shown promise because it helps people adhere to it and reduces body fat. It works by making people feel fuller and more satisfied, aiding weight control over time. Both diet strategies are effective, but they manage weight in different ways. ^{6 7 8 9 10}

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)

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?

Group I: Non-restrictive satiating intervention Experimental Treatment 1 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 intervention Experimental Treatment 1 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 guidelines Placebo Group 1 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

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A bidirectional texting strategy was effective in helping patients with obesity and hypertension initiate and maintain time-restricted eating, with participants adhering for an average of 4.7 days per week in the control group and 5.4 days in the intervention group.

While the intervention did not significantly improve adherence compared to the control group, all participants experienced a meaningful reduction in systolic blood pressure from 135 to 128 mm Hg, indicating potential cardiovascular benefits from time-restricted eating.

NCBI (Pubmed)

pubmed.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. Fanaroff, AC., Coratti, S., Halaby, R., et al.[2023]

In a study involving 138 women with obesity, mindful eating (ME) combined with moderate energy restriction (MER) led to significant weight loss, but there was no notable difference in weight loss between the different intervention groups after 6 months.

Participants in the ME group experienced greater reductions in uncontrolled and emotional eating compared to those in the MER group, suggesting that while ME may improve eating behaviors, it does not necessarily enhance weight loss outcomes beyond what is achieved with energy restriction alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindful eating for weight loss in women with obesity: a randomised controlled trial. Pepe, RB., Coelho, GSMA., Miguel, FDS., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Rates of Adherence and Barriers to Time-Restricted Eating. Jefcoate, PW., Robertson, MD., Ogden, J., et al.[2023]

Intermittent energy restriction (IER) strategies, such as intermittent fasting and time-restricted feeding, show similar effectiveness in weight loss compared to continuous energy restriction (CER) in adults with obesity, based on a review of randomized trials lasting at least 8 weeks.

Out of 11 studies analyzed, 9 found no significant differences in weight or body fat loss between IER and CER, suggesting that IER can be a viable alternative for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Rynders, CA., Thomas, EA., Zaman, A., et al.[2021]

In a 24-week study involving 80 obese participants, calorie restriction (1000-1200 kcal/day) led to significantly greater weight loss and better maintenance of that weight loss over 18 months compared to dietary fat restriction (22-26 g/day).

Calorie restriction also resulted in a greater decrease in body fat percentage and resting metabolic rate, reinforcing the idea that total calorie intake is crucial for effective weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calorie restriction is more effective for obesity treatment than dietary fat restriction. Harvey-Berino, J.[2018]

In a study of 60 participants over 16-20 weeks, those on a low-calorie diet lost significantly more weight than those on a low-fat diet, with males losing an average of 11.8 kg and females 8.2 kg in the low-calorie group compared to 8.0 kg and 3.9 kg in the low-fat group, respectively.

Both diet groups showed similar improvements in eating habits, but adherence issues related to social eating and emotional eating persisted, and follow-up data indicated that weight loss differences diminished over time, with both groups maintaining some weight loss after 9-12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized evaluation of a low fat ad libitum carbohydrate diet for weight reduction. Schlundt, DG., Hill, JO., Pope-Cordle, J., et al.[2014]

Current dietary treatments for obesity primarily focus on reducing caloric intake based on the assumption that obese individuals eat too much, which has shown limited long-term effectiveness, with an average maximum weight loss of only 8.5%.

The success of these interventions is largely influenced by the initial weight of the participants, suggesting that the approach needs reevaluation to consider the quality of food intake rather than just quantity, and to improve the overall effectiveness of obesity treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary treatments of obesity. Bennett, W.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of dietary fat vs. total energy restriction for weight loss. Harvey-Berino, J.[2019]

Obesity is a major global health issue linked to serious diseases like cancer and type II diabetes, making effective prevention and treatment essential.

Successful obesity management involves personalized strategies that include dietary changes, physical activity, and behavior modification, with various evidence-based approaches available such as medications, lifestyle interventions, and bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Nutritional Strategies in the Treatment and Management of Obesity: A Systematic Review. Adeola, OL., Agudosi, GM., Akueme, NT., et al.[2023]

Interventions that change the eating window and timing of meals may lead to weight loss and improvements in heart health, but it's unclear if these benefits come from reduced calorie intake or from syncing food intake with the body's internal clock.

There is limited research on the safety and effectiveness of these timing-based dietary strategies specifically for individuals with chronic diseases like cardiovascular disease, highlighting a need for further studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of time of eating on cardiometabolic risk in primary and secondary prevention of cardiovascular disease. Billingsley, HE.[2023]

The Three-Factor Model of Dieting categorizes dieting into three dimensions: past dieting history, current dieting efforts, and weight suppression, which helps in understanding different dieting behaviors.

The Dieting and Weight History Questionnaire (DWHQ) is a tool developed to assess these dimensions, providing a structured way to evaluate dieting practices and inform future research directions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the three types of dieting in the Three-Factor Model of dieting. The Dieting and Weight History Questionnaire. Witt, AA., Katterman, SN., Lowe, MR.[2022]

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