Effects of Oral Xylitol on Subsequent Energy Intake

University Hospital Basel

Status: Completed

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

Treatments: Dietary Supplement: Sucrose; Dietary Supplement: Xylitol; Dietary Supplement: Water; Dietary Supplement: Acesulfame Potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT05671965

PFI-X

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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21 participants in 4 patient groups, including a placebo group

Xylitol

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Xylitol

Sucrose

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Sucrose

Acesulfame Potassium

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Acesulfame Potassium

Water

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Water