Richardson Centre for Functional Foods & Nutraceuticals
Winnipeg, Manitoba, R3T 2E1, Canada
NCT Number: NCT02569762
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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Notify Me18 year–45 year
All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R3T 2E1, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sucralose or aspartame
Aspartame or sucralose
Time frame: 0-200 mins
Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).
Time frame: 4 times during the 12 weeks period
glucose homeostasis
Time frame: 4 times during the 12 weeks period
to detect bacterial composition in feces and SCFA changes
University of Manitoba
Other
Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
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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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