Acute Effects of the Two Alternative Sweeteners D-allulose and Erythritol on Metabolism
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 19, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedSeptember 29, 2020
September 1, 2020
1 year
July 2, 2019
September 28, 2020
Conditions
Outcome Measures
Primary Outcomes (5)
Effects on GI hormone response - GLP-1
Plasma GLP-1 will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA).
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Effects on GI hormone response - PYY
Plasma PYY, and ghrelin will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA).
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Effects on GI hormone response - ghrelin
Plasma ghrelin will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA).
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Effects on GI hormone response - CCK
Plasma cholecystokinin (CCK) levels will be measured with a sensitive radioimmunoassay using a highly specific antiserum.
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Effects on GI hormone response - motilin
Plasma motilin levels will be measured with a sensitive radioimmunoassay as previously described using 125I \[Nle13\] human motilin as tracer and rabbit anti-human Nle13 motilin antibody (final dilution 1/12000).
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Secondary Outcomes (9)
Effects on glycemic control - plasma glucose
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Effects on glycemic control - plasma insulin
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Effects on glycemic control - plasma c-peptide
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Effects on glycemic control - plasma glucagon
Changes from baseline to three hours after treatment. Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Effects on gastric emptying rate
Changes from baseline to four hours after treatment. Breath samples will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180 and 240minutes (after administration).
- +4 more secondary outcomes
Other Outcomes (1)
Effects on GI tolerance
Changes from baseline to four hours after treatment. GI tolerance will be recorded at time=-10, time=30, time=60, time=90, time=120, time=150, time=180, and time=240minutes.
Study Arms (6)
Erythritol
ACTIVE COMPARATOR18 volunteers receive 50g erythritol dissolved in 300mL tap water via a nasogastric tube
Erythritol + lactisole
ACTIVE COMPARATOR18 volunteers receive 50g erythritol with lactisol (450ppm) dissolved in 300mL tap water via a nasogastric tube
D-allulose
ACTIVE COMPARATOR18 volunteers receive 25g D-allulose dissolved in 300mL tap water via a nasogastric tube
D-allulose + lactisole
ACTIVE COMPARATOR18 volunteers receive 25g D-allulose with lactisole (450ppm) dissolved in 300mL tap water via a nasogastric tube
Tap water
PLACEBO COMPARATOR18 volunteers receive 300mL tap water via a nasogastric tube
Tap water + lactisole
PLACEBO COMPARATOR18 volunteers receive 300mL tap water + lactisole (450ppm) via a nasogastric tube
Interventions
50g erythritol dissolved in 300mL tap water
50g erythritol + lactisole (450ppm) dissolved in 300mL tap water
25g D-allulose + lactisole (450ppm) dissolved in 300mL tap water
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Claraspital
Basel, 4002, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Christin Meyer-Gerspach, PD, PhD
St. Clara Research Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 19, 2019
Study Start
September 1, 2019
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
September 29, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share