Meal Replacement Therapy for Obesity

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Minnesota, Minneapolis, MNObesityMeal Replacement Therapy - DietarySupplement
Eligibility
12 - 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two drugs, phentermine and topiramate, to see if it can help adolescents with severe obesity keep off lost weight.

Eligible Conditions
  • Obesity

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Phentermine/Topiramate (Qsymia)
1
Topiramate Tablets
2
NCOA1 (SRC1) variant

Study Objectives

10 Primary · 0 Secondary · Reporting Duration: Baseline, 1 day of Randomization, Week 26 and Week 52 visits.

58 weeks.
To measure changes in BMI.
Week 52
To measure changes in C-reactive protein (CRP).
Body Weight Changes
To measure changes in hemoglobin A1c.
To measure changes in insulin.
To measure changes in lipids.
To measure changes in oxidized LDL.
Week 52
To measure changes in arterial stiffness.
Week 52
To measure changes in total body fat
To measure changes in visceral fat.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Phentermine/Topiramate (Qsymia)
1
Topiramate Tablets
3
NCOA1 (SRC1) variant

Trial Design

3 Treatment Groups

Phentermine/Topiramate
1 of 3
Meal Replacement Therapy
1 of 3
Placebo
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

143 Total Participants · 3 Treatment Groups

Primary Treatment: Meal Replacement Therapy · Has Placebo Group · Phase 2

Meal Replacement Therapy
DietarySupplement
Experimental Group · 1 Intervention: Meal Replacement Therapy · Intervention Types: DietarySupplement
PlaceboPlaceboComparator Group · 2 Interventions: Phentermine-Topiramate, Placebo · Intervention Types: Drug, Other
Phentermine/TopiramateActiveComparator Group · 2 Interventions: Phentermine-Topiramate, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meal Replacement Therapy
2015
Completed Phase 2
~100

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1 day of randomization, week 26 and week 52 visits.

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,271 Previous Clinical Trials
1,487,849 Total Patients Enrolled
64 Trials studying Obesity
18,974 Patients Enrolled for Obesity
Aaron Kelly, PhDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 12 - 18 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are extremely overweight with a body mass index (BMI) equal to or greater than 120% of the 95th percentile or a BMI of 35 kg/m2 or higher.
References

Frequently Asked Questions

Are young adults eligible for this kind of research?

"According to the inclusion criteria, this trial is for patients aged 12-18. Out of the 893 total clinical trials, 216 are for minors and 677 are for elderly patients." - Anonymous Online Contributor

Unverified Answer

Are there any health risks associated with Meal Replacement Therapy?

"While Phase 2 trials are not as reliable in terms of patient safety data, Meal Replacement Therapy showed some signs of being safe in clinical trials and was given a score of 2." - Anonymous Online Contributor

Unverified Answer

How many total participants are in this research?

"That is correct. If you visit clinicaltrials.gov, you will see that this trial has an open call for participants. The listing was created on August 4th 2021 and the most recent update occurred on October 8th 2022. They are looking to enroll 143 people at a single site." - Anonymous Online Contributor

Unverified Answer

Are there any available appointments for this research project?

"That is correct, the listing on clinicaltrials.gov says that this study is open for recruitment. This particular trial was first advertised on August 4th, 2021 and was last updated October 28th, 2022. They are looking to enroll 143 patients at a single site." - Anonymous Online Contributor

Unverified Answer

What are people using Meal Replacement Therapy to improve?

"Meal Replacement Therapy is a common treatment for tonic-clonic seizures. It can also help patients experiencing lipidemia, lennox gastaut syndrome (lGS), and type 2 diabetes mellitus." - Anonymous Online Contributor

Unverified Answer

Does this research build on other scientific investigations of Meal Replacement Therapy?

"There are currently 20 clinical trials underway that focus on studying Meal Replacement Therapy. 3 of those active trials are in their third and final Phase. The majority of these trials for Meal Replacement Therapy originated in Sherbrooke, Quebec; however, there are a total of 36 locations running studies related to this treatment option." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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