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

NCT ID: NCT04027283

Last Updated: 2020-09-29

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Physiological Satiation Mechanisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Erythritol

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

Group Type ACTIVE_COMPARATOR

Erythritol

Intervention Type DIETARY_SUPPLEMENT

50g erythritol dissolved in 300mL tap water

Erythritol + lactisole

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

Group Type ACTIVE_COMPARATOR

Erythritol + lactisole

Intervention Type DIETARY_SUPPLEMENT

50g erythritol + lactisole (450ppm) dissolved in 300mL tap water

D-allulose

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

Group Type ACTIVE_COMPARATOR

D-allulose

Intervention Type DIETARY_SUPPLEMENT

25g D-allulose dissolved in 300mL tap water

D-allulose + lactisole

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

Group Type ACTIVE_COMPARATOR

D-allulose + lactisole

Intervention Type DIETARY_SUPPLEMENT

25g D-allulose + lactisole (450ppm) dissolved in 300mL tap water

Tap water

18 volunteers receive 300mL tap water via a nasogastric tube

Group Type PLACEBO_COMPARATOR

Tap water

Intervention Type DIETARY_SUPPLEMENT

300mL tap water

Tap water + lactisole

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

Group Type PLACEBO_COMPARATOR

Tap water + lactisole

Intervention Type DIETARY_SUPPLEMENT

300mL tap water + lactisole (450ppm)

Interventions

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Erythritol

50g erythritol dissolved in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Erythritol + lactisole

50g erythritol + lactisole (450ppm) dissolved in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

D-allulose

25g D-allulose dissolved in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

D-allulose + lactisole

25g D-allulose + lactisole (450ppm) dissolved in 300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Tap water

300mL tap water

Intervention Type DIETARY_SUPPLEMENT

Tap water + lactisole

300mL tap water + lactisole (450ppm)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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E968-Erythritol E968-Erythritol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Christin Meyer-Gerspach, PD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Clara Research Ltd.

Locations

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St. Claraspital

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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PolyAlluLac

Identifier Type: -

Identifier Source: org_study_id

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