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Trial record 6 of 1007 for:    Area Under Curve AND insulin

Serum Insulin Response After Acute and Chronic Sucralose Ingestion in Healthy Volunteers With Variable Body Mass Index

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ClinicalTrials.gov Identifier: NCT03703141
Recruitment Status : Completed
First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Guillermo Melendez, Hospital General de México Dr. Eduardo Liceaga

Brief Summary:

The consumption of non-caloric sweeteners has increased worldwide; Current publications suggest its consumption associates to insulin resistance.

The present study aims to demonstrate whether acute or chronic sucralose exposure affects insulin or carbohydrate metabolism or alters systemic inflammatory markers and microbiota in young, healthy adults.

In this prospective, randomized, double-blind, placebo-controlled clinical trial, three groups will be included with 30 healthy volunteers each. Group A will receive sucralose 48 mg/ day, group B 96 mg/day and group C plain water as placebo. Subjects will be exposed to acute (one day) and chronic (seventy days) oral sucralose ingestion. After acute or chronic exposure, volunteers will undergo into an Oral Glucose Tolerance Test (OGTT), taking blood samples at -15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively.

Areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes as described; for C peptide, glucagon, GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide) measure points will be at 0, 30 and 60 minutes only. Differences between one and seventy days AUC means will be compared between the three groups, adjusting for BMI. Besides, initial and final systemic inflammatory markers and inflammatory monocytes levels will be quantified and compare between acute and chronic exposure. Also, a comparison between the percentage of acute and chronic microbiome bacterial population in feces will be made.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Screening
Official Title: Effect of Acute or Chronic Ingestion of Sucralose on Serum Insulin in Young and Healthy Adults: a Randomized, Double-blind, Placebo-controlled Trial
Actual Study Start Date : September 27, 2016
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Sucralose 48 mg
Sucralose 48 mg in 60 ml of water O.D. for ten weeks
Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks
volunteers will take sucralose or placebo daily for 70 days
Other Names:
  • sucralose 96 mg (splenda)/day for ten weeks
  • placebo

Experimental: Sucralose 96 mg
sucralose 96 mg in 60 ml of water O.D. for ten weeks
Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks
volunteers will take sucralose or placebo daily for 70 days
Other Names:
  • sucralose 96 mg (splenda)/day for ten weeks
  • placebo

Placebo Comparator: Placebo
60 ml of water as placebo O.D. for ten weeks
Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks
volunteers will take sucralose or placebo daily for 70 days
Other Names:
  • sucralose 96 mg (splenda)/day for ten weeks
  • placebo




Primary Outcome Measures :
  1. Serum insulin levels [ Time Frame: Change the baseline serum insulin levels at 10 weeks sucralose consumption. ]
    To assess the effect of acute and chronic exposure to different sucralose concentrations differentiating the area under the curve levels in healthy, young volunteers, at a glucose tolerance test of 180 minutes.


Secondary Outcome Measures :
  1. C-peptide serum levels. [ Time Frame: Change the baseline serum insulin levels at 10 weeks sucralose consumption. ]
    To assess the effect of acute and chronic exposure to different sucralose concentrations.

  2. Glucose-dependent insulinotropic polypeptide serum levels. [ Time Frame: Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption. ]
    To assess the effect of acute and chronic exposure to different sucralose concentrations.

  3. Glucagon serum levels [ Time Frame: Change the baseline serum glucagon levels at 10 weeks sucralose consumption. ]
    To assess the effect of acute and chronic exposure to different sucralose concentrations.

  4. Glucagon-like peptide-1 serum levels [ Time Frame: Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption. ]
    To assess the effect of acute and chronic exposure to different sucralose concentrations.

  5. Systemic inflammatory response (pCr, Tumor Necrosis Factor , Internferon -, IL-1, IL-6, IL-12, IL-17, e IL-23 serum levels) [ Time Frame: Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption. ]
    To assess the effect of acute and chronic exposure to different sucralose concentrations.

  6. Inflammatory monocytes (CD14hiCD16+ CD11c+CCR2hiCX3CR1lowCD206-) serum levels. [ Time Frame: Change the baseline serum inflammatory monocytes levels at 10 weeks sucralose consumption. ]
    To assess the effect of acute and chronic exposure to different sucralose concentrations.

  7. Anti-inflammatory markers (IL-4, IL-10, e IL-13) serum levels. [ Time Frame: Change the baseline serum anti-inflammatory markers levels at 10 weeks sucralose consumption. ]
    To assess the effect of acute and chronic exposure to different sucralose concentrations.

  8. Intestinal microbiota composition. [ Time Frame: Change the baseline intestinal microbiota composition at 10 weeks sucralose consumption. ]
    To assess the effect of chronic exposure to different sucralose concentrations.

  9. Body Mass Index (BMI) [ Time Frame: To compare the baseline body weight at 10 weeks sucralose consumption. ]
    To assess the effect of chronic exposure to different sucralose concentrations.

  10. Glucose area under the curve levels [ Time Frame: Change the baseline serum glucose levels at 10 weeks sucralose consumption. ]
    Influence of Body Mass Index on the glucose mean area under the curve levels with different sucralose concentrations.

  11. C-peptide area under the curve levels [ Time Frame: Change the baseline serum C-peptide levels at 10 weeks sucralose consumption. ]
    Influence of Body Mass Index on the C-peptide mean area under the curve levels with different sucralose concentrations.

  12. Glucagon area under the curve levels [ Time Frame: Change the baseline serum glucagon levels at 10 weeks sucralose consumption. ]
    Influence of Body Mass Index on the glucagon mean area under the curve levels with different sucralose concentrations.

  13. GLP-1 area under the curve levels [ Time Frame: Change the baseline serum GLP-1 levels at 10 weeks sucralose consumption. ]
    Influence of Body Mass Index on the GLP-1 mean area under the curve levels with different sucralose concentrations.

  14. Glucose-dependent insulinotropic polypeptide area under the curve levels. [ Time Frame: Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption. ]
    Influence of Body Mass Index on the glucose-dependent insulinotropic polypeptide mean area under the curve levels with different sucralose concentrations.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men or women
  • Ages between 18 and 35 years
  • Must not have suffered chronic noncommunicable or infectious diseases
  • Must have been practicing light-moderate physical activity before the study
  • Normal insulin resistance index according to a homeostatic model value of insulin resistance (HOMA-IR) ≤ 3.8
  • Must not be smokers
  • They must accept not to consume industrialized foods that contain non-caloric sweeteners during their participation in the study and be agree to receive weekly telephone reminders during the protocol
  • Must accept not to consume industrialized beverages containing non-caloric sweeteners during their participation in the study
  • Do not consume alcoholic beverages during their participation in the study, do not have alcoholism history and have not consumed alcoholic beverages for less than two weeks before entering to the protocol
  • Must have Mexican ancestry
  • The volunteers, their parents and grandparents must be from Mexico city metropolitan area
  • They must sign the letter of inform consent, expressing their desire to participate as volunteers in the study

Exclusion Criteria:

  • People who have any kind of serious illness at the time of the selection
  • People who have been diagnosed with Diabetes Mellitus type 1 or type 2
  • People who have been diagnosed with thyroid disease
  • People who have been diagnosed with any adrenal glands disease
  • People who have been diagnosed with insulinoma
  • People who have been diagnosed with malabsorption syndrome
  • People with short bowel history
  • People who have been diagnosed with HIV
  • People who have been diagnosed with any type of neoplasia
  • People who have been diagnosed with acute or chronic liver disease
  • People who have been diagnosed with kidney disease with compromise on serum glucose levels
  • People who have been prescribed with corticosteroid in the last 3 months before entering to the study
  • People who have been prescribed with any type of antibiotic, 4 weeks prior to entering to the protocol
  • People who have been prescribed with any type of non-steroidal anti-inflammatory, 4 weeks prior to entering the protocol
  • People who do not accept to remain in the Clinical Pharmacology Unit during the required time to carry out the oral glucose tolerance curves (4 hours, plus the preparation time)
  • People with night jobs
  • People who did not accept to abstain from consuming industrialized products containing non-caloric sweeteners during their participation in the study
  • People who refused to abstain from consuming industrialized beverages containing non-caloric sweeteners during their participation in the study
  • People who do not accept to abstain from consuming alcoholic beverages during their participation in the study
  • People who have undergone bariatric surgery before the study
  • People with inflammatory bowel disease history
  • People who have smoked at least 3 cigarettes per week in the last 3 months
  • People who do not sign the informed consent letter to participate in the study
  • Women on reproductive age without contraception therapy.
  • Pregnant women
  • Women who are breastfeeding at the time of evaluating their admission to the study,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703141


Sponsors and Collaborators
Hospital General de México Dr. Eduardo Liceaga
Investigators
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Principal Investigator: Guillermo Melendez, MD, MSc Hospital General de Mexico Eduardo Liceaga
  Study Documents (Full-Text)

Documents provided by Guillermo Melendez, Hospital General de México Dr. Eduardo Liceaga:
Study Protocol  [PDF] January 20, 2016
Statistical Analysis Plan  [PDF] January 20, 2016


Additional Information:
Publications of Results:

Other Publications:

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Responsible Party: Guillermo Melendez, Projects record and follow-up chief, Hospital General de México Dr. Eduardo Liceaga
ClinicalTrials.gov Identifier: NCT03703141     History of Changes
Other Study ID Numbers: 261575
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Guillermo Melendez, Hospital General de México Dr. Eduardo Liceaga:
sucralose
insulin
AUC
young
inflammatory markers
intolerance

Additional relevant MeSH terms:
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Insulin
Hypoglycemic Agents
Physiological Effects of Drugs