Acute Effects of the Two Alternative Sweeteners D-allulose and Erythritol on Metabolism

University Hospital Basel

Status: Completed

Conditions: Physiological Satiation Mechanisms

Treatments: Dietary Supplement: Erythritol + lactisole; Dietary Supplement: Erythritol; Dietary Supplement: D-allulose; Dietary Supplement: Tap water + lactisole; Dietary Supplement: D-allulose + lactisole; Dietary Supplement: Tap water

Study type: Interventional

Funder types: Other

Identifiers

NCT04027283

PolyAlluLac

Details and patient eligibility

About

The aim of this project is to investigate the effect of intragastric (ig) D-allulose on metabolic parameters in general and to investigate the effect of sweet taste receptor blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and appetite-related sensations to ig administration of erythritol and D-allulose.

Full description

Erythritol (natural non-caloric sweetener) could be an ideal candidate substitute for sugar as it may reduce caloric intake without compensatory overeating or earlier return of hunger. Moreover, it may serve as a physiological tool to disentangle the effects of gastrointestinal (GI) sweet taste receptor stimulation, (an)orexigenic hormone secretion, and glucose metabolism/caloric content on food intake regulation in vivo in humans. However, its effects on appetite, satiation, and satiety have not been studied systematically. Moreover, the mechanisms underlying erythritol-induced anorexigenic GI hormone release have not been investigated so far.

D-allulose is a sugar substitute with almost zero calories and is naturally occurring in small quantities. Apart from its use as sugar replacement, D-allulose seems to favorably affect glycemic control and metabolism as could be shown in animal trials and in a few human trials. However, to date the effects of D-allulose on GI hormone secretion, appetite-related sensations and glycemic control, are not or insufficiently studied in humans.

The aim of this project is therefore to investigate the effect of intragastric (ig) D-allulose on metabolic parameters in general and to investigate the effect of sweet taste receptor blockade on GI hormone responses, glycemic control, gastric emptying (GE) rates and appetite-related sensations to ig administration of erythritol and D-allulose.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy normal weight subjects with a body-mass index of 19.0-24.9
• Normal eating habits (no diets; no dietary changes)
• Age 18-55 years
• Stable body weight for at least three months
• Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion criteria

• Pre-existing consumption of erythritol or D-allulose on a regular basis (usage of erythritol or D-allulose as sugar replacement; in contrast, erythritol-containing toothpaste is allowed)
• Substance abuse
• Regular intake of medications, except anticonceptives
• Chronic or clinically relevant acute infections
• Pregnancy: although no contraindication, pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants a urine pregnancy test is carried out upon screening.
• Participation in another study with investigational drug within the 30 days preceding and during the present study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 6 patient groups, including a placebo group

Erythritol

Active Comparator group

Description:

18 volunteers receive 50g erythritol dissolved in 300mL tap water via a nasogastric tube

Treatment:

Dietary Supplement: Erythritol

Erythritol + lactisole

Active Comparator group

Description:

18 volunteers receive 50g erythritol with lactisol (450ppm) dissolved in 300mL tap water via a nasogastric tube

Treatment:

Dietary Supplement: Erythritol + lactisole

D-allulose

Active Comparator group

Description:

18 volunteers receive 25g D-allulose dissolved in 300mL tap water via a nasogastric tube

Treatment:

Dietary Supplement: D-allulose

D-allulose + lactisole

Active Comparator group

Description:

18 volunteers receive 25g D-allulose with lactisole (450ppm) dissolved in 300mL tap water via a nasogastric tube

Treatment:

Dietary Supplement: D-allulose + lactisole

Tap water

Placebo Comparator group

Description:

18 volunteers receive 300mL tap water via a nasogastric tube

Treatment:

Dietary Supplement: Tap water

Tap water + lactisole

Placebo Comparator group

Description:

18 volunteers receive 300mL tap water + lactisole (450ppm) via a nasogastric tube

Treatment:

Dietary Supplement: Tap water + lactisole