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Completed

NCT Number: NCT04713137

Effects of Oral Pre-loads on Subsequent Energy Intake

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.

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Key information

Conditions

Energy Intake Appetite Gastrointestinal Hormones Glycemic Control Satiation

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Claraspital

Basel, 4002, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erythritol

Dietary Supplement

50g erythritol dissolved in 300mL tap water.

Other names: E968-Erythritol

Sucrose

Dietary Supplement

33.5g sucrose dissolved in 300mL tap water.

Other names: Saccharose

Sucralose

Dietary Supplement

0.0558g sucralose dissolved in 300mL tap water.

Other names: E955-Sucralose

Water

Dietary Supplement

300mL tap water.

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. 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).

    Plasma GLP-1 will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA).

  2. 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).

    Plasma PYY will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA).

  3. 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).

    Plasma cholecystokinin (CCK) levels will be measured with a sensitive radioimmunoassay using a highly specific antiserum.

  4. 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).

    Plasma ghrelin will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA).

  5. 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).

    Blood glucose concentrations will be measured by a commercial hexokinase-glucose-6-phosphate-dehydrogenase method (Roche, Basel, Switzerland).

  6. 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).

    Insulin will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). The lowest level of insulin that can be detected by this assay is 87 pg/mL when using a 25 µL sample. The intra-assay coefficient of variation for insulin is below 10%, whereas the inter-assay coefficient of variation is below 15%.

  7. 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).

    C-peptide will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). The lowest level of c-peptide that can be detected by this assay is 9.5 pg/mL when using a 25 µL sample. The intra-assay coefficient of variation for c-peptide is below 10%, whereas the inter-assay coefficient of variation is below 15%.

  8. 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).

    Glucagon will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA). The lowest level of glucagon that can be detected by this assay is 13 pg/mL when using a 25 µL sample. The intra-assay coefficient of variation for glucagon is below 10%, whereas the inter-assay coefficient of variation is below 15%.

  9. 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).

    Appetite perceptions (feelings of: a) hunger, b) satiety) are assessed by visual analogue scale (VAS). Visual analogue scales consist of a horizontal, unstructured, 10-cm line representing the minimum (0.0 points) to the maximum rating (10.0 points). Subjects assign a vertical mark across the line to indicate the magnitude of their subjective sensation at the present time point. The measurement is quantified by the distance from the left end of the line (minimum rating) to the subject's vertical mark.

  10. 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).

    GI symptoms will be assessed by use of a checklist including the following questions: abdominal pain, nausea, vomiting, diarrhoea, borborygmi, abdominal distension, eructation and increased flatus.

  11. Sweetness of pre-load

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

    Sweetness is assessed by gLMS. General Labeled Magnitude Scales consist of an unequal, vertical line, which is marked with quasi-logarithmic verbal anchors describing different intensities (e.g. "strongest imaginable", "barely detectable"). Participants are instructed to place a mark on the line where their perceived intensity of sensation lies.

  12. Liking ot the pre-load

    Time frame: Liking of the pre-load will be recorded at t = -10 minutes.

    Liking is assessed by gLMS. General Labeled Magnitude Scales consist of an unequal, vertical line, which is marked with quasi-logarithmic verbal anchors describing different intensities (e.g. "strongest imaginable", "barely detectable"). Participants are instructed to place a mark on the line where their perceived intensity of sensation lies.

  13. Liking of the test meal

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

    Liking is assessed by gLMS. General Labeled Magnitude Scales consist of an unequal, vertical line, which is marked with quasi-logarithmic verbal anchors describing different intensities (e.g. "strongest imaginable", "barely detectable"). Participants are instructed to place a mark on the line where their perceived intensity of sensation lies.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2021
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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