Effect of Acute or Chronic Ingestion of Sucralose on Serum Insulin in Young and Healthy Adults: a Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Serum insulin levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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,
研究组 & 干预措施
Sucralose 48 mg
Sucralose 48 mg in 60 ml of water O.D. for ten weeks
干预措施: sucralose 48 mg (splenda)/day for ten weeks (Dietary Supplement)
Sucralose 96 mg
sucralose 96 mg in 60 ml of water O.D. for ten weeks
干预措施: sucralose 48 mg (splenda)/day for ten weeks (Dietary Supplement)
Placebo
60 ml of water as placebo O.D. for ten weeks
干预措施: sucralose 48 mg (splenda)/day for ten weeks (Dietary Supplement)
结局指标
主要结局
Serum insulin levels
时间窗: 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.
次要结局
- Systemic inflammatory response (pCr, Tumor Necrosis Factor , Internferon -, IL-1, IL-6, IL-12, IL-17, e IL-23 serum levels)(Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption.)
- Inflammatory monocytes (CD14hiCD16+ CD11c+CCR2hiCX3CR1lowCD206-) serum levels.(Change the baseline serum inflammatory monocytes levels at 10 weeks sucralose consumption.)
- Anti-inflammatory markers (IL-4, IL-10, e IL-13) serum levels.(Change the baseline serum anti-inflammatory markers levels at 10 weeks sucralose consumption.)
- C-peptide serum levels.(Change the baseline serum insulin levels at 10 weeks sucralose consumption.)
- Glucose-dependent insulinotropic polypeptide serum levels.(Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption.)
- Glucagon-like peptide-1 serum levels(Change the baseline serum systemic inflammatory response levels at 10 weeks sucralose consumption.)
- Glucagon serum levels(Change the baseline serum glucagon levels at 10 weeks sucralose consumption.)
- Intestinal microbiota composition.(Change the baseline intestinal microbiota composition at 10 weeks sucralose consumption.)
- Body Mass Index (BMI)(To compare the baseline body weight at 10 weeks sucralose consumption.)
- Glucose area under the curve levels(Change the baseline serum glucose levels at 10 weeks sucralose consumption.)
- C-peptide area under the curve levels(Change the baseline serum C-peptide levels at 10 weeks sucralose consumption.)
- Glucagon area under the curve levels(Change the baseline serum glucagon levels at 10 weeks sucralose consumption.)
- GLP-1 area under the curve levels(Change the baseline serum GLP-1 levels at 10 weeks sucralose consumption.)
- Glucose-dependent insulinotropic polypeptide area under the curve levels.(Change the baseline serum glucose-dependent insulinotropic polypeptide levels at 10 weeks sucralose consumption.)
研究者
Guillermo Melendez
Projects record and follow-up chief
Hospital General de México Dr. Eduardo Liceaga