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Effects of Replacing Diet Beverages With Water on Weight Loss and Plasma Glucose Control in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Overweight, Obese

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

DBs at the end of the main meal + Diet

Water at the end of the main meal+ Diet

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring diet beverages, water, diabetes, weight loss, insulin sensitivity

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Diabetic female patient with 6.5<H1AC<7.2.
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.

Sites / Locations

NovinDiet Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Diet Beverages (DBs)

Water

Arm Description

Diet beverages after the main meal+ Diet

Water after the main meal+ Diet

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Fasting plasma glucose

Insulin resistance (HOMA)

Lipid profiles

Waist circumference

BMI

HA1C

Full Information

NCT ID

NCT02412774

First Posted

April 6, 2015

Last Updated

October 24, 2019

Sponsor

Novindiet Clinic

Collaborators

University of Nottingham, Tehran University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02412774

Brief Title

Effects of Replacing Diet Beverages With Water on Weight Loss and Plasma Glucose Control in Type 2 Diabetes

Official Title

Effects of Replacing Diet Beverages With Water on Type 2 Diabetic Obese Females Attending a Weight Loss Program - a Randomized, 24 Week Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

April 2015 (Actual)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novindiet Clinic

Collaborators

University of Nottingham, Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Overweight, Obese

Keywords

diet beverages, water, diabetes, weight loss, insulin sensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diet Beverages (DBs)

Arm Type

Experimental

Arm Description

Diet beverages after the main meal+ Diet

Arm Title

Water

Arm Type

Experimental

Arm Description

Water after the main meal+ Diet

Intervention Type

Behavioral

Intervention Name(s)

DBs at the end of the main meal + Diet

Intervention Description

Subjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan for 24 weeks.

Intervention Type

Behavioral

Intervention Name(s)

Water at the end of the main meal+ Diet

Intervention Description

Subjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan for 24 weeks.

Primary Outcome Measure Information:

Title

Weight loss

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Fasting plasma glucose

Time Frame

24 weeks

Title

Insulin resistance (HOMA)

Time Frame

24 weeks

Title

Lipid profiles

Time Frame

24 weeks

Title

Waist circumference

Time Frame

24 weeks

Title

BMI

Time Frame

24 Weeks

Title

HA1C

Time Frame

24 Weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diabetic female patient with 6.5<H1AC<7.2. 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.

Overall Study Officials: