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NCT05129735 | Unknown status | Diabetes Mellitus, Type 2

An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
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.

Condition or disease

Diabetes Mellitus, Type 2

Intervention/treatment

Meal replacement shake

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 100 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
Actual Study Start Date : September 15, 2022
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022
Arm Intervention/treatment

Experimental: Meal replacement shake

Teatis meal replacement shake

Dietary Supplement: Meal replacement shake
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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
An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.

Location Details

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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.

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Citruslabs

Santa Monica, California, United States, 90404