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Trial registered on ANZCTR


Registration number
ACTRN12621001531808
Ethics application status
Approved
Date submitted
24/03/2021
Date registered
10/11/2021
Date last updated
10/11/2021
Date data sharing statement initially provided
10/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Sucralose intake and glycemic response in obese subjects
Scientific title
Effects of chronic sucralose supplementation on glycemic response, appetite, and gut microbiota in obese subjects: a study protocol
Secondary ID [1] 303748 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 321207 0
Diabetes 321208 0
Condition category
Condition code
Metabolic and Endocrine 318990 318990 0 0
Diabetes
Diet and Nutrition 321742 321742 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of sixty participants will be included: thirty subjects with obesity, otherwise healthy (BMI over 30 kg/m2), and thirty with obesity and type 2 diabetes (T2D). Participants from both groups will be randomly allocated into one of the two treatment phases to receive daily either a) sucralose or b) placebo for eight weeks, each phase separated by four weeks washout period.

A dose of 2.5 mg/kg/day of sucralose from food grade (Tate & Lyle PLC, UK) will be administered to patients in the sucralose-arm. This dose is equivalent to 50% of acceptable daily intake (5 mg/kg/day, FDA). The study product will be provided in ready-to-use sachets to be mixed with a habitual beverage.

Adherence will be evaluated with a specific format in which participants will register the number of sachets consumed each day.
Intervention code [1] 320062 0
Treatment: Other
Comparator / control treatment
Control arm: subjects will receive 2.5 mg/kg/day of sucrose.
Control group
Placebo

Outcomes
Primary outcome [1] 326915 0
24-h Glycemia Incremental Area Under Curve (iAUC)
Timepoint [1] 326915 0
The evaluation period will take place a week immediately before and the week immediately after intervention.
We will insert the iPRO2 continuous glucose monitoring (CGM) system sensor in the periumbilical area to obtain continuous interstitial glucose records every 5-min for a week days during the four evaluation periods (before and after two treatment phases).
Primary outcome [2] 326935 0
Glycemic and insulinemic responses (composite primary outcome).
Timepoint [2] 326935 0
The evaluation period will take place a week immediately before and the week immediately after intervention (second day of each week).
.
Glycemic and insulinemic responses will be determined during a meal tolerance test (MTT). Timepoints at : 0, 15, 30, 60, 90, 120, 150, and 180 min after consuming a standardized breakfast.
Secondary outcome [1] 393110 0
Changes in fasting parameters (Composite secondary outcome).
Glucose, insulin, triglycerides, non-esterified fatty acids (NEFA), and gut hormones (GLP-1, PYY, ghrelin and leptin).
Timepoint [1] 393110 0
Fasting parameters evaluation will take place a week immediately before and the week immediately after intervention (second day of each week).

Fasting values will be obtained from baseline blood samples during the MTT.

Secondary outcome [2] 393111 0
Subjective appetite assessment
Timepoint [2] 393111 0
During the MTT the appetite sensation will be performed through visual analog scales (VAS) at 0, 15, 30, 60, 90, 120, 150, and 180 min after consuming a standardized breakfast.

Secondary outcome [3] 393112 0
Changes in the gut microbiota
Timepoint [3] 393112 0
We will collect fecal samples during the evaluation periods. The bacterial rRNA 16s gene (16S rRNA) of the participants will be processed to monitor gut changes before and after interventions.

Eligibility
Key inclusion criteria
1. Aged 18-50. Both men and women
2. Body Mass Index (BMI) >30 kg/m2
3. Have maintained stable weight during three months prior to intervention
4. Non or low consumers of non-nutritive sweeteners (NNS)
5. No known allergies/intolerances to the NNS
6. Type 2 diabetic with HbA1c < 9.0, under lifestyle control or oral medication such as glibenclamide y/o metformin.
7. Not receiving insulin, or having a history of ketoacidosis
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to give informed consent
2. Pregnant or breast-feeding females
3. Smoker or alcoholic
4. Are allergic to adhesive or having a food intolerance
5. Heart, liver, gastrointestinal or renal disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For sample size calculation the NCSS, PASS v. 11.0 software was used. Two-way repeated measures ANOVA and Tukey test will be used to compare glycemic profiles that will be obtained from CGM and MTT using GraphPad Prism v. 7.0 software. The EasyGV (An Excel-enabled workbook) will be used to analyze glycemic variability from CGM data. QIIME v. 1.9.1 software and G test will be used for gut microbiota analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/02/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 23554 0
Mexico
State/province [1] 23554 0
Tabasco

Funding & Sponsors
Funding source category [1] 308155 0
University
Name [1] 308155 0
Universidad Juárez Autónoma de Tabasco
Country [1] 308155 0
Mexico
Primary sponsor type
University
Name
Universidad Nacional Autonoma de Mexico
Address
Circuito Escolar 411A,
Copilco Universidad,
Coyoacán, 04360
Ciudad de México, CDMX
Country
Mexico
Secondary sponsor category [1] 308955 0
None
Name [1] 308955 0
Address [1] 308955 0
Country [1] 308955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308140 0
Comisión Institucional de Ética en Investigación (CIEI)
Ethics committee address [1] 308140 0
Ethics committee country [1] 308140 0
Mexico
Date submitted for ethics approval [1] 308140 0
22/03/2021
Approval date [1] 308140 0
22/04/2021
Ethics approval number [1] 308140 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109674 0
Dr Jorge Luis Ble Castillo
Address 109674 0
Centro de Investigación
División Académica de Ciencias de la Salud
Universidad Juárez Autónoma de Tabasco
Avenida Gregorio Méndez 2838-A
Colonia Tamulté
Villahermosa, Tabasco, México
C.P. 86150
Country 109674 0
Mexico
Phone 109674 0
+52 1 993 173 5353
Fax 109674 0
Email 109674 0
jblecastillo@hotmail.com
Contact person for public queries
Name 109675 0
Meztli Ramos Garcia
Address 109675 0
Centro de Investigación
Estudiante del Doctorado en Ciencias Biomédicas
División Académica de Ciencias de la Salud
Universidad Juárez Autónoma de Tabasco
Avenida Gregorio Méndez 2838-A
Colonia Tamulté
Villahermosa, Tabasco, México
C.P. 86150
Country 109675 0
Mexico
Phone 109675 0
+52 993 445 6293
Fax 109675 0
Email 109675 0
meztli.garcia@hotmail.com
Contact person for scientific queries
Name 109676 0
Jorge Luis Ble Castillo
Address 109676 0
Centro de Investigación
División Académica de Ciencias de la Salud
Universidad Juárez Autónoma de Tabasco
Avenida Gregorio Méndez 2838-A
Colonia Tamulté
Villahermosa, Tabasco, México
C.P. 86150
Country 109676 0
Mexico
Phone 109676 0
+52 993 173 5353
Fax 109676 0
Email 109676 0
jblecastillo@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.