Effects of Oral Xylitol on Subsequent Energy Intake

NCT05671965 | Completed DMC

• 1 other identifier: PFI-X
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Energy Intake; Gastrointestinal Hormones; Glycemic Control; Appetite; Satiation

Outcome Measures

Primary Outcomes (1)

• Effect of xylitol on energy intake during a subsequent ad libitum test meal

  Fifteen minutes after the administration of the pre-loads (t = 0 minutes), a standard solid test meal will be presented and ad libitum energy intake will be measured.

  Total energy intake will be measured from t = 0 until t = 20 minutes or as soon as the as the subject stops eating for more than 5 minutes.

Secondary Outcomes (13)

• Effects on GI hormone response - GLP-1

  Blood will be drawn at the following time points :t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).

• Effects on GI hormone response - PYY

  Blood will be drawn at the following time points :t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).

• Effects on GI hormone response - CCK

  Blood will be drawn at the following time points: t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).

• Effects on GI hormone response - ghrelin

  Blood will be drawn at the following time points: t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).

• Effects on glycemic control - plasma glucose

  Blood will be drawn at the following time points: t = -16, t = -1 (before administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).

Study Arms (4)

Xylitol

ACTIVE COMPARATOR

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

Dietary Supplement: Xylitol

Sucrose

ACTIVE COMPARATOR

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

Dietary Supplement: Sucrose

Acesulfame Potassium

ACTIVE COMPARATOR

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

Dietary Supplement: Acesulfame Potassium

Water

PLACEBO COMPARATOR

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

Dietary Supplement: Water

Interventions

Xylitol DIETARY_SUPPLEMENT

33.5g xylitol dissolved in 300mL tap water.

Also known as: E967-Xylitol

Xylitol

Sucrose DIETARY_SUPPLEMENT

33.5g sucrose dissolved in 300mL tap water.

Also known as: Saccharose

Sucrose

Acesulfame Potassium DIETARY_SUPPLEMENT

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

Also known as: E950-Ace-K

Acesulfame Potassium

Water DIETARY_SUPPLEMENT

300mL tap water.

Water

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St. Claraspital

Basel, 4002, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39940340 DERIVED

MeSH Terms

Interventions

Xylitol; Sucrose; acetosulfame; Water

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Disaccharides; Oligosaccharides; Polysaccharides; Sugars; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Anne Christin Meyer-Gerspach

  St. Clara Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 5, 2023
• Study Start: January 27, 2023
• Primary Completion: January 31, 2024
• Study Completion: August 15, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)