NCT02459535

Brief Summary

Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes. Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release. However, it is unclear, if these findings are valid for all kinds of AS, as they are chemically different. Furthermore, data on human subjects are sparse and controversial. The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

March 23, 2015

Last Update Submit

June 23, 2020

Conditions

Pre-diabetesDiabetes

Keywords

incretin release

Outcome Measures

Primary Outcomes (7)

  • change in GIP release

    comparison between all seven interventions

    120 mins

  • change in GLP-1 release

    comparison between all seven interventions

    120 mins

  • change in GLP-2 release

    comparison between all seven interventions

    120 mins

  • change in PYY release

    comparison between all seven interventions

    120 mins

  • change in insulin release

    comparison between all seven interventions

    120 mins

  • change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin secretion

    comparison between all seven interventions

    120 mins

  • change in combined blood levels of glucose and insulin, expressed in calculated indices for insulin sensitivity

    comparison between all seven interventions

    120 mins

Study Arms (7)

Glucose only

ACTIVE COMPARATOR

oral ingestion of 54 g Glucose in 300 ml water at t=0 in fasted state; blood samples over 120 mins

Other: oral stimulation glucose

Glucose + Saccharin

ACTIVE COMPARATOR

oral ingestion of 54 g Glucose + 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins

Other: oral stimulation glucoseOther: oral stimulation saccharin

Saccharin only

ACTIVE COMPARATOR

oral ingestion of 0,112 g Saccharin in 300 ml water at t=0 in fasted state; blood samples over 120 mins

Other: oral stimulation saccharin

Glucose + Aspartame

ACTIVE COMPARATOR

oral ingestion of 54 g Glucose 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins

Other: oral stimulation glucoseOther: oral stimulation aspartame

Aspartame only

ACTIVE COMPARATOR

oral ingestion of 0,197 g Aspartame in 300 ml water at t=0 in fasted state; blood samples over 120 mins

Other: oral stimulation aspartame

Glucose + Sucralose

ACTIVE COMPARATOR

oral ingestion of 54 g Glucose + 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins

Other: oral stimulation glucoseOther: oral stimulation sucralose

Sucralose only

ACTIVE COMPARATOR

oral ingestion of 0,088 g Sucralose in 300 ml water at t=0 in fasted state; blood samples over 120 mins

Other: oral stimulation sucralose

Interventions

oral stimulation glucoseOTHER

oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion

Glucose + AspartameGlucose + SaccharinGlucose + SucraloseGlucose only
oral stimulation saccharinOTHER
Glucose + SaccharinSaccharin only
oral stimulation aspartameOTHER
Aspartame onlyGlucose + Aspartame
oral stimulation sucraloseOTHER
Glucose + SucraloseSucralose only

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy

You may not qualify if:

  • metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Institut for Human Nutrition; Department for Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, 14458, Germany

Location

MeSH Terms

Conditions

Glucose IntoleranceDiabetes Mellitus

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Clinical Nutrition

Study Record Dates

First Submitted

March 23, 2015

First Posted

June 2, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2017

Study Completion

July 1, 2019

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

DE(1)