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Completed

NCT Number: NCT02569762

Effects of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

The Objectives of this study is to determine the effect(s) of daily non-caloric artificial sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and also to determine the changes in glucose metabolism.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre for Functional Foods & Nutraceuticals

Winnipeg, Manitoba, R3T 2E1, Canada

About this study

The trial will be 12 weeks randomized, cross-over and double blinded with 2 treatment intervention ( sucralose and aspartame) , there will be a run in period (4 weeks), then phase 1 treatment period for two weeks followed by four weeks washout period then phase 2 treatment period(2 weeks). Healthy, normglycemic (<5.6 mmol/L) males and females ( 17 total) of age 18-45 y with a body mass index (BMI) 20-25 kg/m2 will be recruited.

Each participants will be given the dose of sweetener aspartame or sucralose during the treatment phase in a double-blind procedure.

the participant will be asked to consume the sweetener in a mixed flavoured beverage during each visit in the treatment phase.

Blood and stool sample collection will take place before after the run-in period, and after the washout period, as well as after each two-week treatment period.

glucose measurement: Capillary blood will be collected during each visit by registered nurse. Blood will be collected at fasting and at 12,30,45,60,90 and 120 minutes after the participants drink a glucose drink (75g glucose) for Oral glucose tolerance test.

a food frequency questionnaire will be given to each participant in order to estimate how often each sweetener is consumed on a daily basis.

Participants will also be asked to complete weekly food diaries of food and drink consumption.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 20-25 kg/m2
  • Fasting blood glucose (FBG) < 5.7 mmol/L
  • women with regular menstrual cycle.

Exclusion criteria

  • probiotic or antibiotic use within 6 months prior to the start of the study
  • metabolic or gastrointestinal disorders (diabetes mellitus types 1 and 2, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, phenylketonuria)
  • pregnant or lactating women

Treatment and study plan

Sucralose-Aspartame

Dietary Supplement

Sucralose or aspartame

Aspartame-Sucralose

Dietary Supplement

Aspartame or sucralose

Primary outcomes

  1. Fasting Blood Glucose

    Time frame: 0-200 mins

    Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).

Secondary outcomes

  1. Insulin, glucagon,GIP & GLP-1

    Time frame: 4 times during the 12 weeks period

    glucose homeostasis

  2. Fecal Microbiome & short chain fatty acids measurements

    Time frame: 4 times during the 12 weeks period

    to detect bacterial composition in feces and SCFA changes

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 7, 2015
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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