Skip to main content
OpenTrials
Completed

NCT Number: NCT02580110

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food for Health Science Centre, Medicon Village, Lund University

Lund, , SE-223 81 LUND, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Sucrose

Other

Stevia glycosides

Other

saccharin

Other

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Anti-Diabetic Food Centre

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Jun 23, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.