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

NCT ID: NCT02580110

Last Updated: 2016-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-06-30

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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sucrose

14 days intervention with daily intake of a beverage (1000 ml) including 66g sucrose.

Group Type EXPERIMENTAL

Sucrose

Intervention Type OTHER

stevia glycosides

14 days intervention with daily intake of a beverage (1000ml) including 0.220 g stevia glycosides.

Group Type EXPERIMENTAL

Stevia glycosides

Intervention Type OTHER

saccharin

14 days intervention with daily intake of a beverage (1000ml) including 0.216g saccharin.

Group Type EXPERIMENTAL

saccharin

Intervention Type OTHER

Interventions

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Sucrose

Intervention Type OTHER

Stevia glycosides

Intervention Type OTHER

saccharin

Intervention Type OTHER

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Anti-Diabetic Food Centre

OTHER

Sponsor Role collaborator

Lund University

OTHER

Sponsor Role lead

Responsible Party

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Anne Nilsson

PhD, assocoate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Nilsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Food for Health Science Centre, Lund University

Locations

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Food for Health Science Centre, Medicon Village, Lund University

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2015/57

Identifier Type: -

Identifier Source: org_study_id

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