Very Low Calorie Diet for Obesity

(SAFETY Trial)

Overseen By Devika Umashanker, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hartford Hospital

Must not be taking: Weight loss medications

Disqualifiers: Lactose intolerance, Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a 12-week very low-calorie diet (VLCD) can help individuals with severe obesity (BMI ≥50) lose weight before sleeve gastrectomy, a type of weight-loss surgery. The researchers aim to determine if this diet makes surgery safer and more effective by reducing liver size and other weight-related health issues. Participants will follow a strict meal plan and meet weekly with clinicians to track progress and health. This trial suits those approved for sleeve gastrectomy who can adhere to a diet of meal replacement shakes and vegetables. The study aims to improve pre- and post-surgery care for bariatric patients. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on FDA-approved weight loss medications, you cannot participate in the trial.

What prior data suggests that this very low-calorie diet is safe for patients with Class 4 obesity?

Research has shown that a very low-calorie diet (VLCD) can be safe and effective for people with obesity. Some studies have found that participants can lose a significant amount of weight, around 10 to 15.6 kg. These diets, especially when monitored by a dietitian, are generally safe, with side effects that are usually manageable.

In one study, participants on a VLCD lost an average of about 7.1 kg and experienced a decrease in BMI, a measure of body fat based on height and weight. These results suggest that the VLCD is generally well-tolerated and can be a useful tool for weight loss, particularly when preparing for surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Very Low Calorie Diet (VLCD) for obesity is unique because it drastically reduces daily caloric intake to approximately 800 kcal, which is much lower than typical weight loss diets that usually range from 1,200 to 1,800 kcal per day. Researchers are excited about this approach because it can lead to rapid weight loss, potentially improving obesity-related health issues faster than standard diets. Furthermore, by significantly restricting calories, VLCDs may help reset metabolic processes, offering a new angle for managing obesity that could complement existing treatments like lifestyle changes, medications, and surgery.

What evidence suggests that a very low-calorie diet might be an effective treatment for Class 4 obesity?

Research has shown that a very low-calorie diet (VLCD), which limits daily intake to about 800 calories, can lead to significant weight loss. Studies indicate that people on a VLCD can lose around 13-18% of their body weight. With guidance from a dietitian, 70% of participants lost enough weight to qualify for surgery, though some experienced mild side effects. Another study found that a VLCD led to more weight loss compared to other diets. This trial will evaluate the effectiveness of a VLCD in achieving weight loss before bariatric surgery, potentially making the surgery safer and more successful. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with Class 4 obesity (BMI ≥50Kg/m2) who are approved for sleeve gastrectomy. It aims to see if a strict diet of about 800 calories per day, using protein shakes and vegetables for 12 weeks before surgery, can make the operation safer and improve weight loss outcomes.

Inclusion Criteria

BMI greater than or equal to 50 kg/m2

I am approved for sleeve gastrectomy as my main weight loss surgery.

Able and willing to sign an Informed Consent document

Exclusion Criteria

I am currently taking FDA-approved weight loss medications.

Are lactose intolerant

I have been diagnosed with Type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow a 12-week very low-calorie diet (VLCD) program with weekly in-person visits to assess weight loss, physical and mental health, and adherence to the diet

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for weight loss and health outcomes at 3, 6, and 12 months post-surgery

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Very Low Calorie Diet

Trial Overview The study tests a preoperative very low-calorie diet's feasibility and effectiveness in patients with severe obesity undergoing sleeve gastrectomy. Participants will follow this diet strictly for three months, attending weekly check-ups to monitor their progress.

How Is the Trial Designed?

Group I: Very Low Calorie Diet Experimental Treatment 1 Intervention

Very Low Calorie Diet - caloric intake restricted to approximately 800 kcal/day

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Published Research Related to This Trial

Low and very low calorie diets can effectively initiate weight loss and improve obesity-related health issues, but they should only be used under professional supervision due to the risk of severe complications.

Sustained long-term weight loss relies on making permanent lifestyle changes in diet and physical activity, rather than solely relying on low-calorie diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low and very low calorie diets. Atkinson, RL.[2019]

In a 90-week study involving five seriously overweight individuals, a self-help group model combined with a very-low-calorie diet led to significant and sustained weight loss, with four participants continuing to lose between 33.7 and 66.8 kg.

All subjects maintained a weight well below their starting point, suggesting that this approach may be effective for long-term obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome of a self-help very-low-calorie-diet weight-loss program. Cox, JS., Kreitzman, SN., Coxon, AY., et al.[2018]

The very-low-calorie ketogenic diet (VLCKD) is an effective lifestyle intervention for managing overweight and obesity, leading to significant weight loss and improvements in conditions like hypertension, type 2 diabetes, and dyslipidemia.

This review synthesizes evidence from four key studies, highlighting VLCKD's potential benefits and offering practical recommendations for its implementation in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very-low-calorie ketogenic diet for the management of obesity, overweight and related disorders. Castellana, M., Biacchi, E., Procino, F., et al.[2021]

Very low-calorie diets (VLCDs), providing 800 kcal/day or less, can lead to significant weight loss of 1.5 to 2.5 kg per week, with an average total loss of 20 kg over 12 to 16 weeks, which is more effective than standard low-calorie diets.

VLCDs are generally safe for moderately and severely obese patients when supervised by medical professionals, although long-term weight maintenance remains a challenge; incorporating behavioral therapy and physical activity can help improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very low-calorie diets. National Task Force on the Prevention and Treatment of Obesity, National Institutes of Health. [2022]

Very low calorie diets can lead to significant weight loss, averaging 20 kg in just 12 weeks, making them effective for treating moderate to severe obesity.

When conducted under careful medical supervision for up to 3 months, these diets are considered safe, with no diet-related fatalities reported in over 10,000 cases, contrasting sharply with earlier liquid protein diets that had serious safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very low calorie diets: their efficacy, safety, and future. Wadden, TA., Stunkard, AJ., Brownell, KD.[2022]

In a study of 44 patients with obesity, a Very Low Calorie Diet (VLCD) resulted in an average weight loss of 7 kg and a weight loss rate of 1.2 kg per week, indicating its effectiveness for weight management.

While 33% of participants reported mild side effects, such as constipation and dizziness, the majority (84%) adhered to the VLCD, suggesting that with proper support, adherence can be maintained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of Very Low Calory Diets in obese patients]. Sáez Belló, M., Segarra Villalba, C., Gras Colomer, E., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33016501/

Efficacy of a dietitian-led very low calorie diet (VLCD ... Most patients (70%, n = 50/71) achieved sufficient weight loss to proceed to surgery. Fifty-six per cent of patients reported mild side effects ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424002267

Metabolic effects of very-low calorie diet, Semaglutide, or ... By limiting daily energy intake to less than 800 kilocalories (kcal), VLCD interventions result in approximately 13–18% weight loss [7,8].

3. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15819

The latest evidence and clinical guidelines for use of meal ... Results showed that, despite a 6.6-kg greater weight loss at 12 months for the VLCD, the loss of lean mass was proportionally similar to total ...

4. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)03038-1/fulltext

Weight loss and dropout during a commercial weight-loss ... In an adjusted analysis, the VLCD group lost 2.8 kg (95% CI: 2.5, 3.2) and 3.8 kg (95% CI: 3.2, 4.5) more than did the LCD and restricted normal-food groups, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11289242/

Low-calorie diets are effective for weight loss in patients ... When assessed individually, a VLCD led to significant weight reduction [SMD = − 0.79; CI (− 1.24; − 0.34), p ≤ 0.01, I2 = 90%], as did an LCD [ ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31705259/

Efficacy and safety of very low calorie ketogenic diet ... Twelve studies were included. VLCKD was associated with weight losses of -10.0 kg (I2 = 6%) and - 15.6 kg (I2 = 37%) in studies with a ketogenic phase up to and ...

7. translational-medicine.biomedcentral.com translational-medicine.biomedcentral.com/articles/10.1186/s12967-021-03221-6

VLCKD: a real time safety study in obesity Our study demonstrated that VLCKD is a promising, safe and effective therapeutic tool for people with obesity.

8. academic.oup.com academic.oup.com/ckj/article/17/8/sfae217/7715029

Safety and efficacy of very low calorie diet in patients receiving ... VLCD with dietitian supervision was effective in producing significant weight reduction, with an acceptable safety profile in patients treated ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0039606023007183

Impact of a dietitian-led very low calorie diet clinic on ... Mean weight change was 7.1 ± 6.1 kg loss (5.2 ± 5% body weight, range 4.9% gain to −24.6% loss, P < .001), and mean BMI reduced by 2.4 kg/m2 (P < .001). Just ...