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

Teatis

Status: Withdrawn

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: Meal replacement shake

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129735

20227Teatis

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Meal replacement shake

Experimental group

Description:

Teatis meal replacement shake

Treatment:

Dietary Supplement: Meal replacement shake