Effects of Replacing Diet Beverages With Water on Weight Maintenance of Type 2 Diabetic Obese Women: 18 Months Follow up

October 30, 2018 updated by: Novindiet Clinic

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

the present study aimed to follow up our participants in order to consider the changes in weight and anthropometric measurements after the 12-month weight maintenance as well as the total of 18 months, consisting of the previously described 24 weeks active weight loss and a further 53 weeks weight maintenance. The secondary outcome was to compare the abdominal adiposity, carbohydrate, and lipid metabolism during these periods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diet Beverages
'Diet beverages' after the main meal
Behavioral: DBs at the end of the main meal + weight control program
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.
Experimental: Water
'Water' after the main meal
Behavioral: Water at the end of the main meal+ weight control program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss
Time Frame: 77 weeks
77 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting plasma glucose
Time Frame: 77 weeks
77 weeks
Insulin resistance (HOMA)
Time Frame: 77 weeks
77 weeks
Lipid profiles
Time Frame: 77 weeks
77 weeks
Waist circumference
Time Frame: 77 weeks
77 weeks
BMI
Time Frame: 77 Weeks
77 Weeks
HA1C
Time Frame: 77 Weeks
77 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novindiet Clinic

Collaborators

Tehran University of Medical Sciences
University of Nottingham

Investigators

  • Study Chair: Hamid R Farshchi, MD, PhD, 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
  • Principal Investigator: Ameneh Madjd, Dr, NovinDiet Clinic, School of Life Sciences, The University of Nottingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (Actual)

October 31, 2018

Study Record Updates

Last Update Posted (Actual)

October 31, 2018

Last Update Submitted That Met QC Criteria

October 30, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ND-307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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