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

Sponsor

Novindiet Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02412774

Collaborator

University of Nottingham (Other), Tehran University of Medical Sciences (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Overweight Obese	Behavioral: DBs at the end of the main meal + Diet Behavioral: Water at the end of the main meal+ Diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diet Beverages (DBs) Diet beverages after the main meal+ Diet	Behavioral: DBs at the end of the main meal + Diet 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.
Experimental: Water Water after the main meal+ Diet	Behavioral: Water at the end of the main meal+ Diet 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.

Arm

Intervention/Treatment

Experimental: Diet Beverages (DBs)

Diet beverages after the main meal+ Diet

Behavioral: DBs at the end of the main meal + Diet

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.

Experimental: Water

Water after the main meal+ Diet

Behavioral: Water at the end of the main meal+ Diet

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.

Outcome Measures

Primary Outcome Measures

Weight loss [24 weeks]

Secondary Outcome Measures

Fasting plasma glucose [24 weeks]
Insulin resistance (HOMA) [24 weeks]
Lipid profiles [24 weeks]
Waist circumference [24 weeks]
BMI [24 Weeks]
HA1C [24 Weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NovinDiet Clinic	Tehran		Iran, Islamic Republic of	1913635136

Sponsors and Collaborators

Novindiet Clinic
University of Nottingham
Tehran University of Medical Sciences

Investigators

Study Chair: Hamid R Farshchi, MD, PhD, NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Principal Investigator: Ameneh Madjd, Dr, NovinDiet Clinic, School of Life Sciences, The University of Nottingham
Principal Investigator: Ian A Macdonald, Prof., School of Life Sciences, The University of Nottingham
Principal Investigator: Moira A Taylor, PhD, School of Life Sciences, The University of Nottingham
Principal Investigator: Reza Malekzadeh, Prof., Digestive Disease Research Institute, Tehran University of Medical Sciences
Principal Investigator: Alireza Delavari, MD, Digestive Disease Research Institute, Tehran University of Medical Sciences