Effects of Oral Pre-loads on Subsequent Energy Intake

• Register: ClinicalTrials.gov
• Last refreshed on: 27 December 2021
• Main ID: NCT04713137
• Date of registration: 13/01/2021
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Effects of Oral Pre-loads on Subsequent Energy Intake
• Scientific title: Effects of Oral Pre-loads on Subsequent Energy Intake, Gastrointestinal Hormones, Glycemic Control, Appetite-related Sensations, and Gastrointestinal Tolerance
• Date of first enrolment: February 5, 2021
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04713137
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Anne Christin Meyer-Gerspach, PD, PhD
• Affiliation: St. Clara Research Ltd.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy normal weight subjects with a body-mass index of 19.0-24.9

- Normal eating habits (eating breakfast; no diets; no dietary changes; no
vegetarians/vegans, no intolerances/allergies)

- Age 18-55 years

- Stable body weight (+/- 5%) for at least three months

- Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

- Shift worker

- Fructose intolerance

- Pre-existing consumption of erythritol and/or sucralose more than once a week

- Substance abuse

- Regular intake of medications, except anticontraceptive

- 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. Female participants of childbearing age have to use safe
contraception (oral, injectable, or implantable contraceptives, intrauterine
contraceptive devices, or tubectomy). 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Appetite

Energy Intake

Gastrointestinal Hormones

Satiation

Glycemic Control

Intervention(s)

Dietary Supplement: Erythritol

Dietary Supplement: Water

Dietary Supplement: Sucrose

Dietary Supplement: Sucralose

Primary Outcome(s)

Effect of erythritol on energy intake during a subsequent ad libitum test meal [Time Frame: 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 Outcome(s)

Effects on glycemic control - plasma glucagon [Time Frame: 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).]

Liking of the test meal [Time Frame: Liking of the test meal will be recorded at t = 180 minutes.]

Liking ot the pre-load [Time Frame: Liking of the pre-load will be recorded at t = -10 minutes.]

Sweetness of pre-load [Time Frame: Sweetness of the pre-load will be recorded at t = -10 minutes.]

Effects on appetite-related sensations [Time Frame: Visual analogue scales will be recorded at the following time points: t = -16, t = -1 (before the administration of the pre-loads), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-loads).]

Effects on GI hormone response - CCK [Time Frame: 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 [Time Frame: 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 tolerance [Time Frame: GI tolerance will be recorded at t = -16, -1 (before the administration of the pre-load), 30, 60, 120 and 180 minutes (after the administration of the pre-load).]

Effects on glycemic control - plasma c-peptide [Time Frame: 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).]

Effects on GI hormone response - ghrelin [Time Frame: 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 - GLP-1 [Time Frame: 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 [Time Frame: 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).]

Effects on glycemic control - plasma insulin [Time Frame: 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).]

Secondary ID(s)

PolyFoodIntake

Source(s) of Monetary Support

Please refer to primary and secondary sponsors