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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02580110
Other study ID # 2015/57
Secondary ID
Status Completed
Phase N/A
First received October 14, 2015
Last updated June 22, 2016
Start date October 2015
Est. completion date June 2016

Study information

Verified date June 2016
Source Lund University
Contact n/a
Is FDA regulated No
Health authority Sweden: The Central Ethical review board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Sucrose

Stevia glycosides

saccharin


Locations

Country Name City State
Sweden Food for Health Science Centre, Medicon Village, Lund University Lund

Sponsors (2)

Lead Sponsor Collaborator
Lund University Anti-Diabetic Food Centre

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incremental area under the curve (iAUC) (Glucose tolerance) 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. predose (standardised breakfast), 0, 15, 30, 45, 60, 90, 120, 150, and 180 min post dose. No
Primary Incremental area under the curve (iAUC) (insulin sensitivity). 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. predose, 0 (fasting), 15, 30, 45, 60, 90, 120, 150, and 180 min post-dose. No
Primary Working memory capacity 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. 80 min after the standardised breakfast No
Primary Glut microbiota composition faecal samples are collected at baseline prior to the study and after each 14 day intervention period baseline and after 14 days intervention No
Primary Working memory capacity 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. 120 min No
Primary Working memory capacity 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. 160 min No
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