Group 3- Healthy Lean subjects for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity
Lactisole - Other
Eligibility
18 - 65
All Sexes
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Study Summary

This trial will study the effects of short-term consumption of artificial sweeteners on blood sugar levels and gut bacteria.

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 6 weeks

6 weeks
Blood analyzed by way of NOVA StatStrip Meter and Milliplex Map Kit.
Short chain fatty acid analyses

Trial Safety

Trial Design

4 Treatment Groups

Group 3- Healthy Lean subjects
1 of 4
Group 1- Healthy Lean subjects
1 of 4
Group 4- Healthy Lean subjects
1 of 4
Group 2- Healthy Lean subjects
1 of 4
Active Control

90 Total Participants · 4 Treatment Groups

Primary Treatment: Group 3- Healthy Lean subjects · Has Placebo Group · N/A

Group 3- Healthy Lean subjectsActiveComparator Group · 5 Interventions: Lactisole, Stool sampling, Sodium Saccharin, Assessment of dietary compliance, Oral Glucose Tolerance Test (OGTT) · Intervention Types: Other, Other, Other, Other, Other
Group 1- Healthy Lean subjectsActiveComparator Group · 4 Interventions: Stool sampling, Sodium Saccharin, Assessment of dietary compliance, Oral Glucose Tolerance Test (OGTT) · Intervention Types: Other, Other, Other, Other
Group 4- Healthy Lean subjectsActiveComparator Group · 4 Interventions: Lactisole, Stool sampling, Assessment of dietary compliance, Oral Glucose Tolerance Test (OGTT) · Intervention Types: Other, Other, Other, Other
Group 2- Healthy Lean subjectsActiveComparator Group · 4 Interventions: Stool sampling, Placebo, Assessment of dietary compliance, Oral Glucose Tolerance Test (OGTT) · Intervention Types: Other, Other, Other, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks

Who is running the clinical trial?

Translational Research Institute for Metabolism and Diabetes, FloridaLead Sponsor
40 Previous Clinical Trials
3,450 Total Patients Enrolled
11 Trials studying Obesity
264 Patients Enrolled for Obesity
AdventHealth Translational Research InstituteLead Sponsor
43 Previous Clinical Trials
19,909 Total Patients Enrolled
11 Trials studying Obesity
264 Patients Enrolled for Obesity
Richard Pratley, MDPrincipal InvestigatorTranslational Research Institute for Metabolism and Diabetes
9 Previous Clinical Trials
826 Total Patients Enrolled
1 Trials studying Obesity
29 Patients Enrolled for Obesity

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References