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CompletedNCT04713137

Effects of Oral Pre-loads on Subsequent Energy Intake

Effects of Oral Pre-loads on Subsequent Energy Intake, Gastrointestinal Hormones, Glycemic Control, Appetite-related Sensations, and Gastrointestinal Tolerance

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

The aim of this project is to investigate the effect of erythritol (given as pre-load), compared to sucrose, sucralose, 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

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), erythritol (50g), sucralose (0.0558g), 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 calorie 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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTErythritol50g erythritol dissolved in 300mL tap water.
DIETARY_SUPPLEMENTSucrose33.5g sucrose dissolved in 300mL tap water.
DIETARY_SUPPLEMENTSucralose0.0558g sucralose dissolved in 300mL tap water.
DIETARY_SUPPLEMENTWater300mL tap water.

Timeline

Start date
2021-02-05
Primary completion
2021-06-03
Completion
2021-06-03
First posted
2021-01-19
Last updated
2021-12-16

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT04713137. Inclusion in this directory is not an endorsement.