Clinical trial NCT06799715: Assessments of Metabolic Responses to Acute Oral Administration of Sucrose, Glucose, and Fructose
Official title: Assessments of Metabolic Responses to Acute Oral Administration of Sucrose, Glucose, and Fructose in Healthy Humans
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Hormones
Glycemic Control
Blood Coagulation Function
Gastric Emptying
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to compare the acute metabolic effects of the three sweeteners sucrose, glucose, and fructose on GI hormones (GLP-1, PYY, CCK, and ghrelin).

Furthermore, glycemic control, erythritol and xylitol concentrations, blood coagulation function , blood lipids, uric acid, high-sensitive C-reactive protein (hsCRP), complete blood count, gastric emptying, appetite-related sensations, and GI symptoms will be investigated.

Detailed description: Sugar should not be defined by origin (added sugar, free sugar, simple sugar) but rather by chemical structure (sucrose, glucose, fructose, etc.). Although the disaccharide sucrose is hydrolysed by sucrase into its monosaccharides glucose and fructose, the administration of each of the three sweeteners alone results in different metabolic effects.

Although sucrose, glucose, and fructose are long known sweeteners in food and beverages and their metabolic effects have been extensively studied, there are still no comprehensive studies comparing the three sweeteners in a whole range of parameters. The main inconsistency in the literature is the study design which influences the outcomes. It is important to differentiate whether it is an acute or chronic study, whether the participants are adults or children, are healthy or have T2DM, have normal weight, overweight or obesity, whether the dosage is chosen to be isocaloric or isosweet, whether there is a control group or whether the sweeteners are administered orally or intragastrical.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-diabetic (glycated hemoglobin (HbA1c) \< 5.7%, fasting glucose \< 5.6 mmol/L), and normal weight participants with a body-mass index (BMI) of 19.0-24.9 kg/m2, parameters of complete blood count within normal range
* Age 18-55 years
* Stable body weight (± 5%) for at least three months
* Able to give informed consent as documented by signature

Exclusion Criteria:

* Fructose intolerance
* Any pre-existing diet (e.g., vegetarian diet, vegan diet, sugar free diet, paleo diet, Atkins diet, ketogenic diet) that deviates from normal eating habits
* Regular consumption (\>1/ week) of erythritol or xylitol
* Regular intake of medications, except contraceptives
* Pre-existing impairment of blood coagulation/thrombocyte function (e.g. hereditary, regular intake of anti-coagulant agents (e.g. NSAIDs, heparin, warfarin, etc.))Chronic or clinically relevant acute infections/diseases
* Substance abuse (more than 1 glass wine/beer per day; regular consumption of cannabis, consumption of cocaine, heroin, etc.), regular smoking
* 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. In female participants a urine pregnancy test is carried out upon screening.
* Shift worker
* Participation in another study with investigational drug within the 30 days preceding and during the present study

Primary outcomes:
measure: Effect of sucrose, glucose, fructose, and water on the GI hormone response - GLP-1
timeFrame: Blood will be drawn at the following timepoints: : -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration)
measure: Effect of sucrose, glucose, fructose, and water on the GI hormone response - PYY
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
measure: Effect of sucrose, glucose, fructose, and water on the GI hormone response - CCK
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
measure: Effect of sucrose, glucose, fructose, and water on the GI hormone response - Ghrelin
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
Secondary outcomes:
measure: Effects on glycemic control - plasma glucose
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
measure: Effects on glycemic control - plasma insulin
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
measure: Effects on glycemic control - plasma c-peptide
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
measure: Effects on glycemic control - plasma glucagon
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
measure: Effects on erythritol concentrations
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
measure: Effects on xylitol concentrations
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 120, and 180minutes (after administration).
measure: Effects on blood coagulation function - p-selectin
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120, and 180 minutes (after administration).
measure: Effects on blood coagulation function - sVCAM1
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120, and 180 minutes (after administration).
measure: Effects on blood coagulation function - PF-4
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120, and 180 minutes (after administration).
measure: Effects on blood coagulation function - D-Dimers
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120, and 180 minutes (after administration).
measure: Effects on blood lipids
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120 and 180 minutes (after administration).
measure: Effects on uric acid
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120, and 180 minutes (after administration).
measure: Effects on hsCRP
timeFrame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120, and 180minutes (after administration).
measure: Effects on gastric emptying rate
timeFrame: Breath samples will be drawn at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 240minutes (after administration).
measure: Effects on appetite-related sensations
timeFrame: Visual analogue scales will be recorded at the following time points: -10 and -1 minutes (before administration) and 15, 30, 45, 60, 90, 105, 120, and 180 minutes (after administration).
measure: Effects on GI tolerance
timeFrame: GI tolerance will be recorded atthe following time points: -10 minutes (before administration) and 30, 60, 90,120, 180, and 240 minutes (after administration).
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St. Claraspital
Study officials:
affiliation: St. Clara Research Ltd.
name: Anne Christin Meyer-Gerspach, PD, PhD
role: PRINCIPAL_INVESTIGATOR
References: