Sucralose intake and glycemic response in obese subjects

Not Applicable

• Conditions: Obesity; Diabetes; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12621001531808
• Lead Sponsor: niversidad Nacional Autonoma de Mexico

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-10
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-h Glycemia Incremental Area Under Curve (iAUC) [The evaluation period will take place a week immediately before and the week immediately after intervention.<br>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). ];Glycemic and insulinemic responses (composite primary outcome).[The evaluation period will take place a week immediately before and the week immediately after intervention (second day of each week).<br>.<br>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 Measures

Name	Time	Method
Changes in fasting parameters (Composite secondary outcome).<br>Glucose, insulin, triglycerides, non-esterified fatty acids (NEFA), and gut hormones (GLP-1, PYY, ghrelin and leptin).[Fasting parameters evaluation will take place a week immediately before and the week immediately after intervention (second day of each week).<br><br>Fasting values will be obtained from baseline blood samples during the MTT. <br><br>];Subjective appetite assessment[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. <br><br>];Changes in the gut microbiota [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.<br>]