HealthyNCT03703141
Serum Insulin Response After Acute and Chronic Sucralose Ingestion in Healthy Volunteers With Variable Body Mass Index
A study testing sucralose 48 mg (splenda)/day for ten weeks in people with Healthy, run by Hospital General de México Dr. Eduardo Liceaga.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- sucralose 48 mg (splenda)/day for ten weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2016to 4 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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,
About this study
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
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.
Read more
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.
Read the detailed description
Introduction Overweight and obesity have increased along with the rate of other non-communicable diseases worldwide. At the same time, the consumption of non-caloric sweeteners (NCS) has risen considerably among the general population. Although international organizations such as Joint FAO/WHO Expert Committee on Food Additives (JECFA) has demonstrated NCS are safe; two recent publications suggested its consumption associates with insulin resistance.
Although the authors attributed the metabolic effect to changes in the composition of intestinal microbiota as a consequence of NCS ingestion, these studies lacked a robust clinical methodology, as their design were not randomized, comparative studies and the effect of NCS on systemic inflammation biomarkers were neglected.
Outcomes 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.
Materials and methods It is a prospective, randomized, double-blind, placebo-controlled clinical trial, comparing three groups, with 30 healthy volunteers each, who will receive daily sucralose, for seventy days. After signing off informed consent, the first group will take 48 mg sucralose diluted in 60 mL of water; the second group will receive 96 mg / 60 ml a day, while the last group will receive 60 ml of plain water as placebo.
Inclusion criteria will be either sex, age between 18 and 35 years, with a body mass index (BMI) between 18.5 and 39.0, disease free, with light or moderate physical activity before entering the study, with a HOMA ≤3.8, non-smokers, non-alcohol drinkers, agreeing not to consume neither industrial food nor beverages related to NCS during the study, having Mexican ancestry, living in the Mexico City metropolitan area and signing informed consent to participate in the study.
Exclusion criteria Any acute disease by the time of recruitment, history of Type 1 or 2 diabetes, thyroid disease, adrenal glands disease, insulinoma, malabsorption syndrome, short bowel, HIV, any cancer, liver disease, renal disease, inflammatory bowel disease, have prescribed corticosteroids in the previous three months before enrollment or undergone to bariatric surgery. Having a BMI <18.5 or >39.0, working night shifts, unable to remain at the clinic for at least 5 hours, not accepting to stop consuming industrialized food or beverages containing NCS, not accepting to stop alcohol or tobacco consumption during the study, not consenting to participate, women in childbearing potential without pregnancy control or women pregnant or breastfeeding by the time of enrollment.
Each volunteer will be instructed to drink 60 mL of fluid containing either sucralose or water, every morning before meals for seventy days. Except on day one and day 70, when they will be requested to attend the clinic after fasting at least 8 hours. Two plastic containers to carry stool sample will be provided in advance to each participant and be requested to store a stool sample. At their arrival to the clinic the stool sample will be collected and labeled. Immediately after, they will be asked to drink the corresponding dose to day one or seventy in the presence of the investigators. Once the investigational material be drinking, an Oral Glucose Tolerance Test (OGTT), will be initiated, taking blood samples at
- 15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively. Analysis Demographics per group will be described initially. Following, areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes, as the measure points described above; 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.
Mean differences of AUCs between one and seventy days 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 compared between acute and chronic exposure. Additionally, a comparison of changes between the percentage of acute and chronic microbiome population in feces will be made.
- Conditions
- Healthy
- Being tested
- sucralose 48 mg (splenda)/day for ten weeks
- Keywords
- sucralose, insulin, AUC, young, inflammatory markers, intolerance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sucralose 48 mg (splenda)/day for ten weeksDietary supplement
Also called sucralose 96 mg (splenda)/day for ten weeks, placebo
volunteers will take sucralose or placebo daily for 70 days
| Study group | Role | What they receive |
|---|---|---|
| Sucralose 48 mg | Experimental | Sucralose 48 mg in 60 ml of water O.D. for ten weeks Receives: Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks |
| Sucralose 96 mg | Experimental | sucralose 96 mg in 60 ml of water O.D. for ten weeks Receives: Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks |
| Placebo | Placebo comparator | 60 ml of water as placebo O.D. for ten weeks Receives: Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum insulin levels
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.
Measured: Change the baseline serum insulin levels at 10 weeks sucralose consumption.
Secondary outcomes (14)
C-peptide serum levels.
To assess the effect of acute and chronic exposure to different sucralose concentrations.
Measured: Change the baseline serum insulin levels at 10 weeks sucralose consumption.
Glucose-dependent insulinotropic polypeptide serum levels.
To assess the effect of acute and chronic exposure to different sucralose concentrations.
Measured: Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption.
Glucagon serum levels
To assess the effect of acute and chronic exposure to different sucralose concentrations.
Measured: Change the baseline serum glucagon levels at 10 weeks sucralose consumption.
Glucagon-like peptide-1 serum levels
To assess the effect of acute and chronic exposure to different sucralose concentrations.
Measured: Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption.
Systemic inflammatory response (pCr, Tumor Necrosis Factor , Internferon -, IL-1, IL-6, IL-12, IL-17, e IL-23 serum levels)
To assess the effect of acute and chronic exposure to different sucralose concentrations.
Measured: Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption.
Inflammatory monocytes (CD14hiCD16+ CD11c+CCR2hiCX3CR1lowCD206-) serum levels.
To assess the effect of acute and chronic exposure to different sucralose concentrations.
Measured: Change the baseline serum inflammatory monocytes levels at 10 weeks sucralose consumption.
Anti-inflammatory markers (IL-4, IL-10, e IL-13) serum levels.
To assess the effect of acute and chronic exposure to different sucralose concentrations.
Measured: Change the baseline serum anti-inflammatory markers levels at 10 weeks sucralose consumption.
Intestinal microbiota composition.
To assess the effect of chronic exposure to different sucralose concentrations.
Measured: Change the baseline intestinal microbiota composition at 10 weeks sucralose consumption.
Body Mass Index (BMI)
To assess the effect of chronic exposure to different sucralose concentrations.
Measured: To compare the baseline body weight at 10 weeks sucralose consumption.
Glucose area under the curve levels
Influence of Body Mass Index on the glucose mean area under the curve levels with different sucralose concentrations.
Measured: Change the baseline serum glucose levels at 10 weeks sucralose consumption.
C-peptide area under the curve levels
Influence of Body Mass Index on the C-peptide mean area under the curve levels with different sucralose concentrations.
Measured: Change the baseline serum C-peptide levels at 10 weeks sucralose consumption.
Glucagon area under the curve levels
Influence of Body Mass Index on the glucagon mean area under the curve levels with different sucralose concentrations.
Measured: Change the baseline serum glucagon levels at 10 weeks sucralose consumption.
GLP-1 area under the curve levels
Influence of Body Mass Index on the GLP-1 mean area under the curve levels with different sucralose concentrations.
Measured: Change the baseline serum GLP-1 levels at 10 weeks sucralose consumption.
Glucose-dependent insulinotropic polypeptide area under the curve levels.
Influence of Body Mass Index on the glucose-dependent insulinotropic polypeptide mean area under the curve levels with different sucralose concentrations.
Measured: Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start27 Sep 2016
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Guillermo Melendez, Hospital General de México Dr. Eduardo Liceaga
- Investigators
- Guillermo Melendez, MD, MSc, Principal investigator, Hospital General de Mexico Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703141
- Sponsor's protocol ID
- 261575
- Status last verified
- Oct 2018
- First submitted
- 12 Jul 2018
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PubMed 11234459Garcia LM, da Silva KS, Del Duca GF, da Costa FF, Nahas MV. Sedentary behaviors, leisure-time physical inactivity, and chronic diseases in Brazilian workers: a cross sectional study. J Phys Act Health. 2014 Nov;11(8):1622-34. doi: 10.1123/jpah.2012-0423. Epub 2014 Apr 11.
PubMed 24732950Perez-Rodriguez M, Melendez G, Nieto C, Aranda M, Pfeffer F. Dietary and physical activity/inactivity factors associated with obesity in school-aged children. Adv Nutr. 2012 Jul 1;3(4):622S-628S. doi: 10.3945/an.112.001974.
PubMed 22798003Lewis HB, Forwood SE, Ahern AL, Verlaers K, Robinson E, Higgs S, Jebb SA. Personal and social norms for food portion sizes in lean and obese adults. Int J Obes (Lond). 2015 Aug;39(8):1319-24. doi: 10.1038/ijo.2015.47. Epub 2015 Apr 14.
PubMed 25869600Hernandez B, Gortmaker SL, Colditz GA, Peterson KE, Laird NM, Parra-Cabrera S. Association of obesity with physical activity, television programs and other forms of video viewing among children in Mexico city. Int J Obes Relat Metab Disord. 1999 Aug;23(8):845-54. doi: 10.1038/sj.ijo.0800962.
PubMed 10490786Stamatakis E, Hillsdon M, Mishra G, Hamer M, Marmot M. Television viewing and other screen-based entertainment in relation to multiple socioeconomic status indicators and area deprivation: the Scottish Health Survey 2003. J Epidemiol Community Health. 2009 Sep;63(9):734-40. doi: 10.1136/jech.2008.085902. Epub 2009 Apr 27.
PubMed 19401278Glazier RH, Creatore MI, Weyman JT, Fazli G, Matheson FI, Gozdyra P, Moineddin R, Kaufman-Shriqui V, Booth GL. Density, destinations or both? A comparison of measures of walkability in relation to transportation behaviors, obesity and diabetes in Toronto, Canada. PLoS One. 2014 Jan 14;9(1):e85295. doi: 10.1371/journal.pone.0085295. eCollection 2014.
PubMed 24454837National Research Council (US). The Public Health Effects of Food Deserts: Workshop Summary. Washington (DC): National Academies Press (US); 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK208019/
PubMed 25032337Grotz VL, Munro IC. An overview of the safety of sucralose. Regul Toxicol Pharmacol. 2009 Oct;55(1):1-5. doi: 10.1016/j.yrtph.2009.05.011. Epub 2009 May 21.
PubMed 19464334Neels JG, Olefsky JM. Inflamed fat: what starts the fire? J Clin Invest. 2006 Jan;116(1):33-5. doi: 10.1172/JCI27280.
PubMed 16395402Paredes-Turrubiarte G, Gonzalez-Chavez A, Perez-Tamayo R, Salazar-Vazquez BY, Hernandez VS, Garibay-Nieto N, Fragoso JM, Escobedo G. Severity of non-alcoholic fatty liver disease is associated with high systemic levels of tumor necrosis factor alpha and low serum interleukin 10 in morbidly obese patients. Clin Exp Med. 2016 May;16(2):193-202. doi: 10.1007/s10238-015-0347-4. Epub 2015 Apr 18.
PubMed 25894568Weisberg SP, McCann D, Desai M, Rosenbaum M, Leibel RL, Ferrante AW Jr. Obesity is associated with macrophage accumulation in adipose tissue. J Clin Invest. 2003 Dec;112(12):1796-808. doi: 10.1172/JCI19246.
PubMed 14679176Papapanagiotou A, Siasos G, Kassi E, Gargalionis AN, Papavassiliou AG. Novel Inflammatory Markers in Hyperlipidemia: Clinical Implications. Curr Med Chem. 2015;22(23):2727-43. doi: 10.2174/0929867322666150520095008.
PubMed 25989910Borgeson E, Johnson AM, Lee YS, Till A, Syed GH, Ali-Shah ST, Guiry PJ, Dalli J, Colas RA, Serhan CN, Sharma K, Godson C. Lipoxin A4 Attenuates Obesity-Induced Adipose Inflammation and Associated Liver and Kidney Disease. Cell Metab. 2015 Jul 7;22(1):125-37. doi: 10.1016/j.cmet.2015.05.003. Epub 2015 Jun 4.
PubMed 26052006Walther G, Obert P, Dutheil F, Chapier R, Lesourd B, Naughton G, Courteix D, Vinet A. Metabolic syndrome individuals with and without type 2 diabetes mellitus present generalized vascular dysfunction: cross-sectional study. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1022-9. doi: 10.1161/ATVBAHA.114.304591. Epub 2015 Feb 5.
PubMed 25657309
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03703141
- Acronym / sponsor ID
- 261575
- Conditions
- Healthy
- Keywords
- sucralose, insulin, AUC, young, inflammatory markers, intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hospital General de México Dr. Eduardo LiceagaOther government
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction Overweight and obesity have increased along with the rate of other non-communicable diseases worldwide. At the same time, the consumption of non-caloric sweeteners (NCS) has risen considerably among the general population. Although international organizations such as Joint FAO/WHO Expert Committee on Food Additives (JECFA) has demonstrated NCS are safe; two recent publications suggested its consumption associates with insulin resistance.
Although the authors attributed the metabolic effect to changes in the composition of intestinal microbiota as a consequence of NCS ingestion, these studies lacked a robust clinical methodology, as their design were not randomized, comparative studies and the effect of NCS on systemic inflammation biomarkers were neglected.
Outcomes 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.
Materials and methods It is a prospective, randomized, double-blind, placebo-controlled clinical trial, comparing three groups, with 30 healthy volunteers each, who will receive daily sucralose, for seventy days. After signing off informed consent, the first group will take 48 mg sucralose diluted in 60 mL of water; the second group will receive 96 mg / 60 ml a day, while the last group will receive 60 ml of plain water as placebo.
Inclusion criteria will be either sex, age between 18 and 35 years, with a body mass index (BMI) between 18.5 and 39.0, disease free, with light or moderate physical activity before entering the study, with a HOMA ≤3.8, non-smokers, non-alcohol drinkers, agreeing not to consume neither industrial food nor beverages related to NCS during the study, having Mexican ancestry, living in the Mexico City metropolitan area and signing informed consent to participate in the study.
Exclusion criteria Any acute disease by the time of recruitment, history of Type 1 or 2 diabetes, thyroid disease, adrenal glands disease, insulinoma, malabsorption syndrome, short bowel, HIV, any cancer, liver disease, renal disease, inflammatory bowel disease, have prescribed corticosteroids in the previous three months before enrollment or undergone to bariatric surgery. Having a BMI <18.5 or >39.0, working night shifts, unable to remain at the clinic for at least 5 hours, not accepting to stop consuming industrialized food or beverages containing NCS, not accepting to stop alcohol or tobacco consumption during the study, not consenting to participate, women in childbearing potential without pregnancy control or women pregnant or breastfeeding by the time of enrollment.
Each volunteer will be instructed to drink 60 mL of fluid containing either sucralose or water, every morning before meals for seventy days. Except on day one and day 70, when they will be requested to attend the clinic after fasting at least 8 hours. Two plastic containers to carry stool sample will be provided in advance to each participant and be requested to store a stool sample. At their arrival to the clinic the stool sample will be collected and labeled. Immediately after, they will be asked to drink the corresponding dose to day one or seventy in the presence of the investigators. Once the investigational material be drinking, an Oral Glucose Tolerance Test (OGTT), will be initiated, taking blood samples at
- 15, 0, 15, 30, 45, 60, 75, 90, 105, 120 and 180 minutes, respectively. Analysis Demographics per group will be described initially. Following, areas under the curve (AUC) for insulin and glucose, will be calculated from zero to one hundred and eighty minutes, as the measure points described above; 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.
Mean differences of AUCs between one and seventy days 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 compared between acute and chronic exposure. Additionally, a comparison of changes between the percentage of acute and chronic microbiome population in feces will be made.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sucralose 48 mg | Experimental | Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeksSucralose 48 mg in 60 ml of water O.D. for ten weeks |
| Sucralose 96 mg | Experimental | Dietary Supplement: sucralose 48 mg (splenda)/day for ten weekssucralose 96 mg in 60 ml of water O.D. for ten weeks |
| Placebo | Placebo comparator | Dietary Supplement: sucralose 48 mg (splenda)/day for ten weeks60 ml of water as placebo O.D. for ten weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sucralose 48 mg (splenda)/day for ten weeksAlso: sucralose 96 mg (splenda)/day for ten weeks, placebovolunteers will take sucralose or placebo daily for 70 days | Dietary supplement | Placebo, Sucralose 48 mg, Sucralose 96 mg |
Primary outcome
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.
14 secondary outcomes
C-peptide serum levels.
Time frame: Change the baseline serum insulin levels at 10 weeks sucralose consumption.
Glucose-dependent insulinotropic polypeptide serum levels.
Time frame: Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption.
Glucagon serum levels
Time frame: Change the baseline serum glucagon levels at 10 weeks sucralose consumption.
Glucagon-like peptide-1 serum levels
Time frame: Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption.
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.
Inflammatory monocytes (CD14hiCD16+ CD11c+CCR2hiCX3CR1lowCD206-) serum levels.
Time frame: Change the baseline serum inflammatory monocytes levels at 10 weeks sucralose consumption.
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.
Intestinal microbiota composition.
Time frame: Change the baseline intestinal microbiota composition at 10 weeks sucralose consumption.
Body Mass Index (BMI)
Time frame: To compare the baseline body weight at 10 weeks sucralose consumption.
Glucose area under the curve levels
Time frame: Change the baseline serum glucose levels at 10 weeks sucralose consumption.
C-peptide area under the curve levels
Time frame: Change the baseline serum C-peptide levels at 10 weeks sucralose consumption.
Glucagon area under the curve levels
Time frame: Change the baseline serum glucagon levels at 10 weeks sucralose consumption.
GLP-1 area under the curve levels
Time frame: Change the baseline serum GLP-1 levels at 10 weeks sucralose consumption.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Background: PubMed 11234459Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Background: PubMed 24732950Garcia LM, da Silva KS, Del Duca GF, da Costa FF, Nahas MV. Sedentary behaviors, leisure-time physical inactivity, and chronic diseases in Brazilian workers: a cross sectional study. J Phys Act Health. 2014 Nov;11(8):1622-34. doi: 10.1123/jpah.2012-0423. Epub 2014 Apr 11.
- Background: PubMed 22798003Perez-Rodriguez M, Melendez G, Nieto C, Aranda M, Pfeffer F. Dietary and physical activity/inactivity factors associated with obesity in school-aged children. Adv Nutr. 2012 Jul 1;3(4):622S-628S. doi: 10.3945/an.112.001974.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Melendez, MD, MSc principal investigator
Hospital General de Mexico Eduardo Liceaga
Questions about this trial
What is this clinical trial studying?
A study testing sucralose 48 mg (splenda)/day for ten weeks in people with Healthy, run by Hospital General de México Dr. Eduardo Liceaga.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum insulin levels (time frame: Change the baseline serum insulin levels at 10 weeks sucralose consumption.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03703141, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.