An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Dietary Supplement: Meal replacement shake
- Registration Number
- NCT05129735
- Lead Sponsor
- Teatis, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Meal replacement shake Meal replacement shake Teatis meal replacement shake
- Primary Outcome Measures
Name Time Method Improvement of quality of life score from baseline to 12-weeks 12 weeks Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score)
- Secondary Outcome Measures
Name Time Method Improvement in total cholesterol levels from baseline to 12-weeks 12 weeks Change in total cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Improvement in triglyceride levels from baseline to 12-weeks 12 weeks Change in triglyceride measured with an at-home blood test after 12 weeks compared to baseline results.
Improvement in HDL cholesterol levels from baseline to 12-weeks 12 weeks Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Improvement in a1c levels from baseline to 12-weeks 12 weeks Change in a1c biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.
Improvement in blood glucose from baseline to 12-weeks 12 weeks Change in blood glucose biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.
Improvement in insulin levels from baseline to 12-weeks 12 weeks Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results.
Improvement in LDL cholesterol levels from baseline to 12-weeks 12 weeks Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Trial Locations
- Locations (1)
Citruslabs
🇺🇸Santa Monica, California, United States