Healthy Subjects Clinical Trial
Official title:
On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sweden | Food for Health Science Centre, Medicon Village, Lund University | Lund |
Lead Sponsor | Collaborator |
---|---|
Lund University | Anti-Diabetic Food Centre |
Sweden,
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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