Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2

NCT ID: NCT02487537

Last Updated: 2020-06-24

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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. Metabolic assessment will be based on oral glucose tolerance tests.

Conditions

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Diabetes Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Non-sweetened soft drink

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

Group Type PLACEBO_COMPARATOR

custom-made soft drink

Intervention Type DIETARY_SUPPLEMENT

Sweetened soft drink

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

Group Type ACTIVE_COMPARATOR

custom-made soft drink

Intervention Type DIETARY_SUPPLEMENT

Interventions

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custom-made soft drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* healthy

Exclusion Criteria

* no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Andreas F. H. Pfeiffer

Director, Department of Clinical Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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German Institut for Human Nutrition; Department for Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 32449201 (View on PubMed)

Other Identifiers

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ILIAS-2

Identifier Type: -

Identifier Source: org_study_id

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