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

June 22, 2016 updated by: Anne Nilsson, Lund University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, , SE-223 81 LUND
        • Food for Health Science Centre, Medicon Village, Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: sucrose
14 days intervention with daily intake of a beverage (1000 ml) including 66g sucrose.
Other: Sucrose
Experimental: stevia glycosides
14 days intervention with daily intake of a beverage (1000ml) including 0.220 g stevia glycosides.
Other: Stevia glycosides
Experimental: saccharin
14 days intervention with daily intake of a beverage (1000ml) including 0.216g saccharin.
Other: saccharin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
predose (standardised breakfast), 0, 15, 30, 45, 60, 90, 120, 150, and 180 min post dose.
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.
predose, 0 (fasting), 15, 30, 45, 60, 90, 120, 150, and 180 min post-dose.
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.
80 min after the standardised breakfast
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
baseline and after 14 days intervention
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.
120 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.
160 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lund University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Anti-Diabetic Food Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Nilsson, PhD, Food for Health Science Centre, Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015/57

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