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

NCT ID: NCT02412774

Last Updated: 2019-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Overweight Obese

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diet Beverages (DBs)

Diet beverages after the main meal+ Diet

Group Type EXPERIMENTAL

DBs at the end of the main meal + Diet

Intervention Type BEHAVIORAL

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.

Water

Water after the main meal+ Diet

Group Type EXPERIMENTAL

Water at the end of the main meal+ Diet

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Nottingham

OTHER

Sponsor Role collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role collaborator

Novindiet Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hamid R Farshchi, MD, PhD

Role: STUDY_CHAIR

NovinDiet Clinic, School of Life Sciences, The University of Nottingham

Ameneh Madjd, Dr

Role: PRINCIPAL_INVESTIGATOR

NovinDiet Clinic, School of Life Sciences, The University of Nottingham

Ian A Macdonald, Prof.

Role: PRINCIPAL_INVESTIGATOR

School of Life Sciences, The University of Nottingham

Moira A Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Life Sciences, The University of Nottingham

Reza Malekzadeh, Prof.

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Research Institute, Tehran University of Medical Sciences

Alireza Delavari, MD

Role: PRINCIPAL_INVESTIGATOR

Digestive Disease Research Institute, Tehran University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NovinDiet Clinic

Tehran, , Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

References

Explore related publications, articles, or registry entries linked to this study.

Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.

Reference Type DERIVED
PMID: 32449201 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ND-107

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Hydration to Optimize Metabolism
NCT03422848 COMPLETED NA