On the Impact of Common Sweetening Agents on Glucose Regulation, Cognitive Functioning and Gut Microbiota
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 14, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 23, 2016
June 1, 2016
8 months
October 14, 2015
June 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (3)
sucrose
EXPERIMENTAL14 days intervention with daily intake of a beverage (1000 ml) including 66g sucrose.
stevia glycosides
EXPERIMENTAL14 days intervention with daily intake of a beverage (1000ml) including 0.220 g stevia glycosides.
saccharin
EXPERIMENTAL14 days intervention with daily intake of a beverage (1000ml) including 0.216g saccharin.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- diabetes
- cognitive decline (not able to cope with the cognitive tests)
- metabolic syndrome
- gastro-intestinal disorders
- antibiotics or probiotics during the study period
- smookers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
- Anti-Diabetic Food Centrecollaborator
Study Sites (1)
Food for Health Science Centre, Medicon Village, Lund University
Lund, , SE-223 81 LUND, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Nilsson, PhD
Food for Health Science Centre, Lund University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, assocoate professor
Study Record Dates
First Submitted
October 14, 2015
First Posted
October 20, 2015
Study Start
October 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 23, 2016
Record last verified: 2016-06