Effects of Oral Pre-loads on Subsequent Energy Intake

NCT ID: NCT04713137

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-05

Study Completion Date

2021-06-03

Brief Summary

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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

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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

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Energy Intake Gastrointestinal Hormones Glycemic Control Appetite Satiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Erythritol

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

Group Type ACTIVE_COMPARATOR

Erythritol

Intervention Type DIETARY_SUPPLEMENT

50g erythritol dissolved in 300mL tap water.

Sucrose

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

Group Type ACTIVE_COMPARATOR

Sucrose

Intervention Type DIETARY_SUPPLEMENT

33.5g sucrose dissolved in 300mL tap water.

Sucralose

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

Group Type ACTIVE_COMPARATOR

Sucralose

Intervention Type DIETARY_SUPPLEMENT

0.0558g sucralose dissolved in 300mL tap water.

Water

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

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

300mL tap water.

Interventions

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Erythritol

50g erythritol dissolved in 300mL tap water.

Intervention Type DIETARY_SUPPLEMENT

Sucrose

33.5g sucrose dissolved in 300mL tap water.

Intervention Type DIETARY_SUPPLEMENT

Sucralose

0.0558g sucralose dissolved in 300mL tap water.

Intervention Type DIETARY_SUPPLEMENT

Water

300mL tap water.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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E968-Erythritol Saccharose E955-Sucralose

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Christin Meyer-Gerspach, PD, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Clara Research Ltd.

Locations

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St. Claraspital

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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PolyFoodIntake

Identifier Type: -

Identifier Source: org_study_id