Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1 (ILIAS-1)

German Institute of Human Nutrition

Status: Completed

Conditions: Diabetes; Pre-diabetes

Treatments: Other: oral stimulation aspartame; Other: oral stimulation saccharin; Other: oral stimulation sucralose; Other: oral stimulation glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT02459535

ILIAS-1

Details and patient eligibility

About

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.

Full description

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. Up to now, no single study has ever compared metabolic responses to different AS in the same subjects. Furthermore, data on human subjects are sparse and controversial. This is partially explained by different methodical approaches such as intragastral/intraduodenal application of AS, rather than conventional oral consumption.

The investigators will therefore conduct 7 consecutive single oral stimulations with glucose or AS alone or a combination. Three different AS will be tested: saccharin, aspartame and sucralose.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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14 participants in 7 patient groups

Glucose only

Active Comparator group

Description:

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

Treatment:

Other: oral stimulation glucose

Glucose + Saccharin

Active Comparator group

Description:

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

Treatment:

Other: oral stimulation saccharin

Other: oral stimulation glucose

Saccharin only

Active Comparator group

Description:

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

Treatment:

Other: oral stimulation saccharin

Glucose + Aspartame

Active Comparator group

Description:

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

Treatment:

Other: oral stimulation glucose

Other: oral stimulation aspartame

Aspartame only

Active Comparator group

Description:

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

Treatment:

Other: oral stimulation aspartame

Glucose + Sucralose

Active Comparator group

Description:

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

Treatment:

Other: oral stimulation glucose

Other: oral stimulation sucralose

Sucralose only

Active Comparator group

Description:

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

Treatment:

Other: oral stimulation sucralose