Healthy Clinical Trial
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.
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.
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.
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