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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580110
• Other study ID #: 2015/57
• 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

• Healthy Subjects

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