Effects of Oral Xylitol on Subsequent Energy Intake

NCT ID: NCT05671965

Last Updated: 2024-08-19

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-27

Study Completion Date

2024-08-15

Brief Summary

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The aim of this project is to investigate the effect of xylitol (given as pre-load), compared to sucrose, Ace-K, and water on energy intake during a subsequent ad libitum test meal in healthy participants.

Furthermore, the release of GI hormones, glycemic control, appetite-related sensations, GI tolerance, sweetness and liking in response to the pre-loads will be investigated.

Detailed Description

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The subjects will participate in four study days. The screening will last 60 minutes, the study days about 4.5 hours each. After a simple-carbohydrate standard dinner, the subjects have to do an overnight fast until the next morning. Subjects will receive fixed equisweet doses of sucrose (33.5g), xylitol (33.5g), Ace-K (0.1675g), or water as oral pre-loads in a blinded, randomized (counterbalanced) fashion (t = -15 min). Fifteen minutes after the administration (t = 0 min), a standard solid test meal will be presented and ad libitum energy intake will be measured. The end of the test meal will be after 20 minutes or as soon as the subject stops eating for more than 5 minutes. Blood samples (to measure: glycemic control and GI hormones) will be collected at t = -16, t = -1, t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 min and appetite-related sensation rating will be collected at t = -16, t = -1, t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 min. GI symptoms and nausea are assessed at t = -16, -1, 30, 60, 120 and 180 min. At t = -10 min subjects are asked to rate the perceived sweetness and liking of the pre-load and at t = 180 min the perceived liking of the test meal.

Conditions

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Energy Intake Gastrointestinal Hormones Glycemic Control Appetite Satiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xylitol

20 volunteers receive 33.5g xylitol dissolved in 300mL tap water as an oral pre-load.

Group Type ACTIVE_COMPARATOR

Xylitol

Intervention Type DIETARY_SUPPLEMENT

33.5g xylitol dissolved in 300mL tap water.

Sucrose

20 volunteers receive 33.5g sucrose dissolved in 300mL tap water as an oral pre-load.

Group Type ACTIVE_COMPARATOR

Sucrose

Intervention Type DIETARY_SUPPLEMENT

33.5g sucrose dissolved in 300mL tap water.

Acesulfame Potassium

20 volunteers receive 0.1675g Ace-K dissolved in 300mL tap water as an oral pre-load.

Group Type ACTIVE_COMPARATOR

Acesulfame Potassium

Intervention Type DIETARY_SUPPLEMENT

0.1675g Ace-K dissolved in 300mL tap water.

Water

20 volunteers receive 300mL tap water as an oral pre-load.

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

300mL tap water.

Interventions

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Xylitol

33.5g xylitol dissolved in 300mL tap water.

Intervention Type DIETARY_SUPPLEMENT

Sucrose

33.5g sucrose dissolved in 300mL tap water.

Intervention Type DIETARY_SUPPLEMENT

Acesulfame Potassium

0.1675g Ace-K dissolved in 300mL tap water.

Intervention Type DIETARY_SUPPLEMENT

Water

300mL tap water.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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E967-Xylitol Saccharose E950-Ace-K

Eligibility Criteria

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Inclusion Criteria

* Healthy normal weight participants (10 male and 10 female) with a body-mass index (BMI) of 19.0-24.9 kg/m2
* Age 18-55 years
* Stable body weight (± 5%) for at least three months
* Able to give informed consent as documented by signature

Exclusion Criteria

* Fructose intolerance
* Pre-existing diet (vegetarian, vegan, sugar free, no breakfast)
* Pre-existing regular consumption of xylitol and/or Ace-K (\> 1/week)
* Chronic or clinically relevant acute infections/diseases
* Regular intake of medications, except contraceptives
* Pregnancy: although no contraindication, pregnancy might influence metabolic state.
* Substance abuse (more than 1 glass wine/beer per day; consumption of cannabis, cocaine, heroin, etc.)
* Shift worker
* 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

Role: PRINCIPAL_INVESTIGATOR

St. Clara Research Ltd.

Locations

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St. Claraspital

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Flad E, Altstadt A, Beglinger C, Rehfeld JF, Van Oudenhove L, Wolnerhanssen BK, Meyer-Gerspach AC. Effects of Oral Xylitol, Sucrose, and Acesulfame Potassium on Total Energy Intake During a Subsequent ad libitum Test Meal: A Randomized, Controlled, Crossover Trial in Healthy Humans. Nutrients. 2025 Jan 29;17(3):484. doi: 10.3390/nu17030484.

Reference Type DERIVED
PMID: 39940340 (View on PubMed)

Other Identifiers

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PFI-X

Identifier Type: -

Identifier Source: org_study_id

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