Dietary Habits for Post-Bariatric Surgery Weight Loss

Overseen By Raphael Knaier, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Insulin-dependent diabetes, Anemia, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different dietary plans can improve weight loss for patients who have undergone bariatric surgery, specifically sleeve gastrectomy. Two diet plans are being tested, but details remain confidential until after enrollment. Suitable candidates for this trial have had sleeve gastrectomy surgery and do not have conditions such as insulin-dependent diabetes, anemia, or PTSD. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance post-surgery weight loss strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these dietary habit interventions are safe for post-bariatric surgery patients?

Research has shown that after bariatric surgery, following specific eating habits is crucial for losing weight and maintaining it. Prospective participants in a clinical trial examining post-surgery eating habits should know that these approaches are safe.

Dietary habits plan A aligns with post-surgery guidelines. It begins with a liquid diet, progresses to soft foods, and finally to solid foods. The focus remains on balanced nutrition, emphasizing foods high in protein and fiber, which are generally easy to digest. Some individuals may experience "dumping syndrome," where food moves too quickly through the stomach, especially after consuming sugary foods.

Dietary habits plan B starts with protein-rich liquids like yogurt and soups. This plan gradually reintroduces different foods while monitoring nutrient intake. Adjustments may be necessary to avoid nutrient deficiencies.

Overall, these eating plans are widely recommended and considered safe, aiding patients in maintaining weight loss. Following the guidelines is important to minimize side effects and achieve optimal results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial of dietary habits for post-bariatric surgery weight loss because it explores new dietary strategies tailored specifically for individuals who have undergone weight loss surgery. Unlike typical post-surgery care that often focuses on generalized nutritional guidelines, this trial aims to uncover specific dietary patterns that could enhance weight loss and long-term weight maintenance. By examining different dietary habits in a structured way, the study hopes to identify actionable insights that could lead to more personalized and effective nutritional plans for post-bariatric patients.

What evidence suggests that this trial's dietary habit interventions could be effective for post-bariatric surgery weight loss?

This trial will compare two dietary habits plans for post-bariatric surgery weight loss. Research has shown that certain eating habits after weight-loss surgery can aid in weight loss. Participants may be assigned to Dietary Habits Plan A, which involves eating balanced meals in small portions, drinking plenty of water, and focusing on foods high in protein and fiber. Studies suggest that mindful eating and attention to portion sizes are also important. Alternatively, participants may follow Dietary Habits Plan B, which emphasizes balanced meals low in calories, fats, and sweets, and gradually introduces soft foods. Although no perfect diet exists, these eating patterns can encourage healthier food choices, potentially aiding weight loss after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Frank Scheer, PhD

Principal Investigator

Brigham and Women's Hospital

Ali Tavakkoli, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone bariatric surgery, specifically sleeve gastrectomy, and are not currently smokers or dependent on drugs or alcohol. It's also important that they don't have bipolar disorder, anemia, PTSD, insulin-dependent diabetes or haven't done shift work in the past year.

Inclusion Criteria

I have had a sleeve gastrectomy.

Exclusion Criteria

Shift work within the past 1 year

Drug or alcohol dependency

I use insulin to manage my diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bariatric surgery followed by dietary habit interventions

4 weeks

1 visit (in-person) for surgery, weekly follow-ups (virtual)

Follow-up

Participants are monitored for changes in self-rated hunger, caloric intake, energy expenditure, and glucose tolerance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary habits plan

Trial Overview The study is examining how following a specific dietary habits plan can influence weight loss results after patients have had bariatric surgery. The goal is to see if these dietary changes improve the effectiveness of the surgery.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 1 Intervention

Subject will be advised to follow dietary habits plan B. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.

Group II: Group A Experimental Treatment 1 Intervention

Subject will be advised to follow dietary habits plan A. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. mayoclinic.org mayoclinic.org/tests-procedures/gastric-bypass-surgery/in-depth/gastric-bypass-diet/art-20048472

Gastric bypass diet: What to eat after the surgery The gastric bypass diet can help you recover from surgery and transition to a way of eating that is healthy and supports your weight-loss goals.

2. ucsfhealth.org ucsfhealth.org/education/dietary-guidelines-after-bariatric-surgery

Dietary Guidelines After Bariatric Surgery Eat balanced meals with small portions. · Follow a diet low in calories, fats and sweets. · Keep a daily record of your food portions and of your calorie and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10345057/

Patients' Perspectives on Dietary Patterns and Eating ... In all, food quality, energy intake, and eating-related problems influence weight management after bariatric surgery. However, nutritional ...

4. adventhealth.com adventhealth.com/practice/adventhealth-weight-loss-and-bariatric-surgery/blog/9-essential-eating-habits-after-bariatric-surgery

9 Essential Eating Habits After Bariatric Surgery Mindful and Slow Eating · Watch Your Portion Sizes · Stay Hydrated · Don't Forget Your Protein · Fiber Is Your Friend · Remember Your Supplements.

5. hackensackmeridianhealth.org hackensackmeridianhealth.org/en/healthu/2022/06/15/what-can-you-eat-after-weight-loss-surgery

What Can You Eat After Weight Loss Surgery? Day One: Clear Liquid Diet​​ Within the first 24 hours after weight loss surgery, you will be placed on a clear liquid diet. Clear liquids ...

6. asmbs.org asmbs.org/patients/life-after-bariatric-surgery/

Life After Bariatric Surgery Most patients will start out on a liquid diet for some weeks, then will slowly start to take soft foods, and then eventually solid foods.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322007256

Nutritional Recommendations for Adult Bariatric Surgery ... The consumption of simple carbohydrates may lead to dumping syndrome (DS), and fiber-rich foods, such as fruit, vegetables, and whole grains, should be consumed ...

8. mdpi.com mdpi.com/2072-6643/17/3/474

Dietary Habits, Obesity, and Bariatric Surgery: A Review of ... While bariatric surgery can lead to substantial weight loss, maintaining this weight loss over time is closely tied to modifications in eating habits.