NCT02412774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 25, 2019

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

April 6, 2015

Last Update Submit

October 24, 2019

Conditions

Type 2 DiabetesOverweightObese

Keywords

diet beverageswaterdiabetesweight lossinsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    24 weeks

Secondary Outcomes (6)

  • Fasting plasma glucose

    24 weeks

  • Insulin resistance (HOMA)

    24 weeks

  • Lipid profiles

    24 weeks

  • Waist circumference

    24 weeks

  • BMI

    24 Weeks

  • +1 more secondary outcomes

Study Arms (2)

Diet Beverages (DBs)

EXPERIMENTAL

Diet beverages after the main meal+ Diet

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

Water

EXPERIMENTAL

Water after the main meal+ Diet

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

Interventions

DBs at the end of the main meal + DietBEHAVIORAL

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.

Diet Beverages (DBs)
Water at the end of the main meal+ DietBEHAVIORAL

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.

Water

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetic female patient with 6.5\<H1AC\<7.2.
  • Monotherapy with Metformin.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NovinDiet Clinic

Tehran, 1913635136, Iran

Location

Related Publications (1)

  • 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.

    PMID: 32449201DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesityDiabetes MellitusWeight LossInsulin Resistance

Interventions

Diet

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesHyperinsulinism

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Hamid R Farshchi, MD, PhD

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

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Study Start

April 1, 2015

Primary Completion

October 1, 2015

Study Completion

January 1, 2016

Last Updated

October 25, 2019

Record last verified: 2019-10

Locations

IR(1)