On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lund University
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Incremental area under the curve (iAUC) (Glucose tolerance)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •healthy subjects
- •blood glucose <6.1
- •age between 40-70 years
- •normal diet
- •fluent in Swedish language (due to the structure of the cognitive tests).
Exclusion Criteria
- •cognitive decline (not able to cope with the cognitive tests)
- •metabolic syndrome
- •gastro-intestinal disorders
- •antibiotics or probiotics during the study period
Arms & Interventions
stevia glycosides
14 days intervention with daily intake of a beverage (1000ml) including 0.220 g stevia glycosides.
Intervention: Stevia glycosides (Other)
saccharin
14 days intervention with daily intake of a beverage (1000ml) including 0.216g saccharin.
Intervention: saccharin (Other)
sucrose
14 days intervention with daily intake of a beverage (1000 ml) including 66g sucrose.
Intervention: Sucrose (Other)
Outcomes
Primary Outcomes
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: 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.
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: 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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Anne Nilsson
PhD, assocoate professor
Lund University