Effects of Oral Pre-loads on Subsequent Energy Intake

NCT04713137 | Completed DMC

• 1 other identifier: PolyFoodIntake
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Effect of erythritol 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 calorie 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)

Erythritol

ACTIVE COMPARATOR

20 volunteers receive 50g erythritol dissolved in 300mL tap water as an oral pre-load.

Dietary Supplement: Erythritol

Sucrose

ACTIVE COMPARATOR

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

Dietary Supplement: Sucrose

Sucralose

ACTIVE COMPARATOR

20 volunteers receive 0.0558g sucralose dissolved in 300mL tap water as an oral pre-load.

Dietary Supplement: Sucralose

Water

PLACEBO COMPARATOR

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

Dietary Supplement: Water

Interventions

Erythritol DIETARY_SUPPLEMENT

50g erythritol dissolved in 300mL tap water.

Also known as: E968-Erythritol

Erythritol

Sucrose DIETARY_SUPPLEMENT

33.5g sucrose dissolved in 300mL tap water.

Also known as: Saccharose

Sucrose

Sucralose DIETARY_SUPPLEMENT

0.0558g sucralose dissolved in 300mL tap water.

Also known as: E955-Sucralose

Sucralose

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 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

St. Claraspital

Basel, 4002, Switzerland

Location

MeSH Terms

Interventions

Erythritol; Sucrose; trichlorosucrose; 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, PD, PhD

  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: January 13, 2021
• First Posted: January 19, 2021
• Study Start: February 5, 2021
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)