Back to resultsAn Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
Primary Purpose
Diabetes Mellitus, Type 2
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Meal replacement shake
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Meal replacement shake
Arm Description
Teatis meal replacement shake
Outcomes
Primary Outcome Measures
Improvement of quality of life score from baseline to 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
Improvement in a1c levels from baseline to 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
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
Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results.
Improvement in total cholesterol levels from baseline to 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
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
Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Improvement in LDL cholesterol levels from baseline to 12-weeks
Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Full Information
NCT ID
NCT05129735
First Posted
November 3, 2021
Last Updated
April 25, 2022
Sponsor
Teatis, Inc
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05129735
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teatis, Inc
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is an open-label single-arm observational trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Meal replacement shake
Arm Type
Experimental
Arm Description
Teatis meal replacement shake
Intervention Type
Dietary Supplement
Intervention Name(s)
Meal replacement shake
Intervention Description
Each day for the study period (12 weeks), the participants will take one meal-replacement shake per day for breakfast. The breakfast will be replaced by the shake entirely.
Primary Outcome Measure Information:
Title
Improvement of quality of life score from baseline to 12-weeks
Description
Survey based quality of life measure on a scale from 0-5 (0=lowest possible score, 5=highest possible score)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Improvement in a1c levels from baseline to 12-weeks
Description
Change in a1c biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.
Time Frame
12 weeks
Title
Improvement in blood glucose from baseline to 12-weeks
Description
Change in blood glucose biomarkers measured with an at-home blood test after 12 weeks compared to baseline results.
Time Frame
12 weeks
Title
Improvement in insulin levels from baseline to 12-weeks
Description
Change in insulin levels measured with an at-home blood test after 12 weeks compared to baseline results.
Time Frame
12 weeks
Title
Improvement in total cholesterol levels from baseline to 12-weeks
Description
Change in total cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Time Frame
12 weeks
Title
Improvement in triglyceride levels from baseline to 12-weeks
Description
Change in triglyceride measured with an at-home blood test after 12 weeks compared to baseline results.
Time Frame
12 weeks
Title
Improvement in HDL cholesterol levels from baseline to 12-weeks
Description
Change in HDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Time Frame
12 weeks
Title
Improvement in LDL cholesterol levels from baseline to 12-weeks
Description
Change in LDL cholesterol measured with an at-home blood test after 12 weeks compared to baseline results.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Renner, MSc
Phone
4242450284
Email
hello@citruslabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Mitschke, MSc
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Renner, MSc
Phone
424-245-0284
Email
hello@citruslabs.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
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