NCT02487537

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. Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable diabetes

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
3 months until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
1.9 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

DiabetesPre-diabetes

Keywords

incretin release

Outcome Measures

Primary Outcomes (7)

  • change in release of GIP

    change in fasting state and post-glucose release of GIP between the two interventions

    4 weeks (cross-over)

  • change in release of GLP-1

    change in fasting state and post-glucose release of GLP-1 between the two interventions

    4 weeks (cross-over)

  • change in release of GLP-2

    change in fasting state and post-glucose release of GLP-2 between the two interventions

    4 weeks (cross-over)

  • change in release of PYY

    change in fasting state and post-glucose release of PYY between the two interventions

    4 weeks (cross-over)

  • change in release of insulin

    change in fasting state and post-glucose release of insulin between the two interventions

    4 weeks (cross-over)

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

    change in fasting state and post-glucose insulin secretion between the two interventions

    4 weeks (cross-over)

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

    change in fasting state and post-glucose insulin sensitivity between the two interventions

    4 weeks (cross-over)

Study Arms (2)

Non-sweetened soft drink

PLACEBO COMPARATOR

4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance

Dietary Supplement: custom-made soft drink

Sweetened soft drink

ACTIVE COMPARATOR

4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage

Dietary Supplement: custom-made soft drink

Interventions

custom-made soft drinkDIETARY_SUPPLEMENT
Non-sweetened soft drinkSweetened soft drink

Eligibility Criteria

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

You may qualify if:

  • healthy

You may not qualify if:

  • no 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

Related Publications (1)

  • Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.

    PMID: 32449201DERIVED

MeSH Terms

Conditions

Diabetes MellitusGlucose Intolerance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Study Design

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

Study Record Dates

First Submitted

March 23, 2015

First Posted

July 1, 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)