NCT02412774CompletedNot Applicable
Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial
Novindiet Clinic2 sites in 2 countries81 target enrollmentStarted: April 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 2
- Primary Endpoint
- Weight loss
Study Overview
Brief Summary
The purpose of the present study is to evaluate the effect of replacing diet beverages with water on weight loss and biochemical indicators for insulin sensitivity and cardiometabolic risk factors of diabetic obese and overweight female adults when they are in a multidisciplinary weight loss plan.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diabetic female patient with 6.5<H1AC<7.
- •Monotherapy with Metformin.
- •18-45 years of age.
- •Body mass index (BMI) between 27-35 kg/ m².
- •Consume DBs regularly during their habitual diet.
- •Must be able to have moderate exercise.
- •Must be interested to have weight loss.
Exclusion Criteria
- •Participating in a research project involving weight loss or physical activity in the previous six months.
- •Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
- •Taking medication that could affect metabolism or change body weight.
- •Report heart problems, chest pain, and cancer within the last five years.
- •Unwilling to change intake of beverages during the study period.
Outcomes
Primary Outcomes
Weight loss
Time Frame: 24 weeks
Secondary Outcomes
- HA1C(24 Weeks)
- Fasting plasma glucose(24 weeks)
- Waist circumference(24 weeks)
- Lipid profiles(24 weeks)
- BMI(24 Weeks)
- Insulin resistance (HOMA)(24 weeks)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow upOverweightType 2 DiabetesObeseNCT03726762Novindiet Clinic81
Completed
Not Applicable
Water Beverage Intervention Trial for Reducing Risk Factors of Metabolic Syndrome in Young Mexican Free Living WomenMetabolic SyndromeNCT01245010Mexican National Institute of Public Health240
Completed
Not Applicable
Childcare Healthy Beverage Access, Food and Beverage Intake, and ObesityObesityNCT05112185Stanford University1,034
Completed
Unknown
Investigation of the effect of water drinking on hangover symptomshealthy subjectsJPRN-UMIN000050305Oita University20
Completed
Not Applicable
The Acute Effect of and Energy Drink vs. Water Consumption on MAP, HR, and Energy MetabolismCardiovascular DiseasesDietHypertensionNCT06330649The University of Texas at Arlington32