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On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota

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ClinicalTrials.gov Identifier: NCT02580110
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
Anti-Diabetic Food Centre
Information provided by (Responsible Party):
Anne Nilsson, Lund University

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE October 20, 2015
Last Update Posted Date June 23, 2016
Study Start Date  ICMJE October 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2015)
  • Incremental area under the curve (iAUC) (Glucose tolerance) [ Time Frame: predose (standardised breakfast), 0, 15, 30, 45, 60, 90, 120, 150, and 180 min post dose. ]
    The iAUC are determined after a standardized breakfast based on white wheat bread (50g available starch). The breakfast was commenced at time=0 and consumed within 10-12 min.
  • Incremental area under the curve (iAUC) (insulin sensitivity). [ Time Frame: predose, 0 (fasting), 15, 30, 45, 60, 90, 120, 150, and 180 min post-dose. ]
    The iAUC are determined after a standardized breakfast based on white wheat bread (50g available starch). The breakfast was commenced at time=0 and consumed within 10-12 min.
  • Working memory capacity [ Time Frame: 80 min after the standardised breakfast ]
    Working memory capacity determined with an oral working memory test composed of short sentences that can be semantically meaningful or not. 3-5 sentences are read to the subject. After each sentence the subject immediately has to reply if the sentence is semantically meaningful or not. After the set of 3-5 sentences the subjects have to recall the first noun in each of the sentences. One test is composed of 12 set with (3-5) sentences.
  • Glut microbiota composition [ Time Frame: baseline and after 14 days intervention ]
    faecal samples are collected at baseline prior to the study and after each 14 day intervention period
  • Working memory capacity [ Time Frame: 120 min ]
    Working memory capacity determined with an oral working memory test composed of short sentences that can be semantically meaningful or not. 3-5 sentences are read to the subject. After each sentence the subject immediately has to reply if the sentence is semantically meaningful or not. After the set of 3-5 sentences the subjects have to recall the first noun in each of the sentences. One test is composed of 12 set with (3-5) sentences.
  • Working memory capacity [ Time Frame: 160 min ]
    Working memory capacity determined with an oral working memory test composed of short sentences that can be semantically meaningful or not. 3-5 sentences are read to the subject. After each sentence the subject immediately has to reply if the sentence is semantically meaningful or not. After the set of 3-5 sentences the subjects have to recall the first noun in each of the sentences. One test is composed of 12 set with (3-5) sentences.
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2015)
  • Glucose tolerance [ Time Frame: Change from baseline glucose tolerance after14 days intervention with sucrose, saccharin, and stevia glycosides, respectively ]
    Glucose tolerance are determined using the 0-180 min incremental area under the curve (iAUC)s starting from fasting glucose concentrations. Blood glucose concentrations are determined at fasting and at 15, 30, 45, 60, 90, 120, 150, and 180 min after a standardised breakfast, after each intervention period. In addition, 0-120 min blood glucose iAUCs are prior to start of the first intervention period (baseline value)
  • insulin sensitivity [ Time Frame: Change from baseline insulin sensitivity after14 days intervention with sucrose, saccharin, and stevia glycosides, respectively ]
    Serum insulin are determined using the 0-180 min incremental area under the curve (iAUC)s starting from fasting insulin concentrations. Insulin concentrations are determined at fasting and at 15, 30, 45, 60, 90, 120, 150, and 180 min after a standardised breakfast, after each intervention period. In addition, 0-120 min insulin iAUCs are prior to start of the first intervention period (baseline value)
  • Working memory capacity [ Time Frame: 14 days ]
    Oral working memory tests are performed at 3 time points on the 3h experimental day after each interventions. Each test takes approximately 8 min to perform.
  • Glut flora composition [ Time Frame: Change from baseline gut flora composition after14 days intervention with sucrose, saccharin, and stevia glycosides, respectively ]
    Stool samples are delivered prior to start of the study and after each 14 days intervention periods
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
Official Title  ICMJE On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
Brief Summary The study intention is to investigate, in healthy humans, effects of 3 commonly used sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut microbiota composition.
Detailed Description Healthy subjects will be included in a crossover study with the purpose to investigate effects of 3 commonly used sweeteners on cardiometabolic risk markers, cognitive functions, and influences on gut microbiota composition. The subjects will consume each test product for 14 days in a random order, separated by at least a two-week washout period. On the last day in each intervention period, i.e. at day fifteen, the last test portion will be consumed together with a standardized evening meal at 9.00 pm. Thereafter the subjects are fasting until arriving to the experimental unit. Upon arrival, test variables in blood will be determined at fasting and repeatedly for 3h postprandial a standardised breakfast served approximately at 8.00 am. Cognitive performance will be determined in the postprandial period with tests evaluating working memory capacity, selective attention, psychomotor reaction time, and executive functions. After each intervention period, faecal samples will be collected for characterization of gut microflora.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Other: Sucrose
  • Other: Stevia glycosides
  • Other: saccharin
Study Arms  ICMJE
  • Experimental: sucrose
    14 days intervention with daily intake of a beverage (1000 ml) including 66g sucrose.
    Intervention: Other: Sucrose
  • Experimental: stevia glycosides
    14 days intervention with daily intake of a beverage (1000ml) including 0.220 g stevia glycosides.
    Intervention: Other: Stevia glycosides
  • Experimental: saccharin
    14 days intervention with daily intake of a beverage (1000ml) including 0.216g saccharin.
    Intervention: Other: saccharin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2016)
39
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2015)
40
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy subjects
  • blood glucose <6.1
  • BMI <28
  • age between 40-70 years
  • normal diet
  • fluent in Swedish language (due to the structure of the cognitive tests).

Exclusion Criteria:

  • diabetes
  • cognitive decline (not able to cope with the cognitive tests)
  • metabolic syndrome
  • gastro-intestinal disorders
  • antibiotics or probiotics during the study period
  • smookers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02580110
Other Study ID Numbers  ICMJE 2015/57
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne Nilsson, Lund University
Study Sponsor  ICMJE Lund University
Collaborators  ICMJE Anti-Diabetic Food Centre
Investigators  ICMJE
Principal Investigator: Anne Nilsson, PhD Food for Health Science Centre, Lund University
PRS Account Lund University
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP