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

German Institute of Human Nutrition

Status: Completed

Conditions: Diabetes; Pre-diabetes

Treatments: Dietary Supplement: custom-made soft drink

Study type: Interventional

Funder types: Other

Identifiers

NCT02487537

ILIAS-2

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.

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.

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.

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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy

Exclusion criteria

• no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Non-sweetened soft drink

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: custom-made soft drink

Sweetened soft drink

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: custom-made soft drink