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Very Low Calorie Diet for Obesity (SAFETY Trial)

N/A

Waitlist Available

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 1 through 12 of the 12 week vlcd program

Awards & highlights

SAFETY Trial Summary

This trial aims to test the feasibility and effectiveness of a 12-week very low-calorie diet (VLCD) program for patients with severe obesity who are undergoing weight loss surgery. The study will enroll

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include fatigue, nutrient deficiencies, mood changes, or gallstones due to rapid weight loss. Close monitoring during the trial aims to manage any adverse effects promptly.

SAFETY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 1 through 12 of the 12 week vlcd program

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 1 through 12 of the 12 week vlcd program

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 through 12 of the 12 week vlcd program for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants who complete the 12-week VLCD program

Secondary outcome measures

Consumption of 3-5 meal replacement shakes plus 2 cups of vegetables per day for 5 to 7 days

VLCD acceptability

Other outcome measures

Weight in pounds

SAFETY Trial Design

1Treatment groups

Experimental Treatment

Group I: Very Low Calorie DietExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor

133 Previous Clinical Trials

18,902 Total Patients Enrolled

5 Trials studying Obesity

415 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which criteria must individuals meet in order to be eligible for enrollment in this research study?

"To be eligible for enrollment in this clinical trial, potential participants must meet the criteria of being between 18 and 70 years old and have obesity. The study aims to recruit a total of 30 qualified candidates."

Answered by AI

Are new participants currently being recruited for this ongoing medical study?

"As per the information available on clinicaltrials.gov, this particular trial is not currently seeking participants. The initial posting of the trial occurred on January 5th, 2024, and it was most recently updated on December 13th, 2023. However, there are still a noteworthy number of other studies (1102 in total) that are actively enrolling participants at this time."

Answered by AI

Is the age range for participants in this study inclusive of individuals who are 55 years or older?

"Applicants who meet the inclusion criteria for this research must be between 18 and 70 years old. It is worth noting that there are currently 188 studies available specifically for patients under the age of 18, as well as an additional 718 studies catering to individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAFETY)

2024. "Acceptability and Feasibility of a Preoperative Very Low Calorie Diet Intervention on Surgical Weight Loss Outcomes (SAFETY)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06183034.