Clinical trial NCT05129735: An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
Official title: An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Teatis, Inc
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2021-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label single-arm observational trial
Primary purpose: TREATMENT

Brief summary: This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or Female between 18-75 years old
* Diagnosed with type 2 diabetes for at least 3 months
* HbA1c of 7.5 to 10% inclusive
* BMI of 27 to 40 kg/m2
* If on any medication, treated with a stable dose for at least 90 days
* Must be in good health (don't report any medical conditions asked in the screening questionnaire)
* Willing and able to provide written informed consent
* Must have a Glucometer at home

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months
* Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study
* Allergies to any test product ingredients
* Has any of the following medical conditions:
* Oncological conditions
* Psychiatric disease
* Cardiovascular disease: any hospitalization within the past 3 months
* Multiple Sclerosis
* Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.
* Any other severe chronic disease
* History of drug or alcohol abuse
* Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study
* Participation in a clinical research trial within 30 days prior to screening
* Participating in an investigational health product research study
* Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol

Primary outcomes:
measure: Improvement of quality of life score from baseline to 12-weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Improvement in a1c levels from baseline to 12-weeks
timeFrame: 12 weeks
measure: Improvement in blood glucose from baseline to 12-weeks
timeFrame: 12 weeks
measure: Improvement in insulin levels from baseline to 12-weeks
timeFrame: 12 weeks
measure: Improvement in total cholesterol levels from baseline to 12-weeks
timeFrame: 12 weeks
measure: Improvement in triglyceride levels from baseline to 12-weeks
timeFrame: 12 weeks
measure: Improvement in HDL cholesterol levels from baseline to 12-weeks
timeFrame: 12 weeks
measure: Improvement in LDL cholesterol levels from baseline to 12-weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke, MSc
role: PRINCIPAL_INVESTIGATOR
References: