Clinical trial NCT02580110: On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
Official title: On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: no specific condition
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Anti-Diabetic Food Centre
First posted: 2015-10-20
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incremental area under the curve (iAUC) (Glucose tolerance)
timeFrame: predose (standardised breakfast), 0, 15, 30, 45, 60, 90, 120, 150, and 180 min post dose.
measure: Incremental area under the curve (iAUC) (insulin sensitivity).
timeFrame: predose, 0 (fasting), 15, 30, 45, 60, 90, 120, 150, and 180 min post-dose.
measure: Working memory capacity
timeFrame: 80 min after the standardised breakfast
measure: Glut microbiota composition
timeFrame: baseline and after 14 days intervention
measure: Working memory capacity
timeFrame: 120 min
measure: Working memory capacity
timeFrame: 160 min
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Food for Health Science Centre, Medicon Village, Lund University
Study officials:
affiliation: Food for Health Science Centre, Lund University
name: Anne Nilsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: