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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: Sucrose
* Other: Stevia glycosides
* Other: saccharin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sucrose<br>14 days intervention with daily intake of a beverage (1000 ml) including 66g sucrose. | Other: Sucrose<br> <br> |
| Experimental: stevia glycosides<br>14 days intervention with daily intake of a beverage (1000ml) including 0.220 g stevia glycosides. | Other: Stevia glycosides<br> <br> |
| Experimental: saccharin<br>14 days intervention with daily intake of a beverage (1000ml) including 0.216g saccharin. | Other: saccharin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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no specific condition