- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06799715
Assessments of Metabolic Responses to Acute Oral Administration of Sucrose, Glucose, and Fructose
Assessments of Metabolic Responses to Acute Oral Administration of Sucrose, Glucose, and Fructose in Healthy Humans
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Basel, Switzerland, 4002
- St. Claraspital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Sucrose
20 volunteers receive 33.5g sucrose dissolved in 300mL water as a drink.
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33.5g sucrose dissolved in 300mL tap water
Other Names:
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Active Comparator: Glucose
20 volunteers receive 33.5g glucose dissolved in 300mL water as a drink.
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33.5g glucose dissolved in 300mL tap water
Other Names:
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Active Comparator: Fructose
20 volunteers receive 33.5g fructose dissolved in 300mL water as a drink.
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33.5g fructose dissolved in 300mL tap water
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Placebo Comparator: Water
20 volunteers receive 300mL water as a drink.
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300mL water
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Effect of sucrose, glucose, fructose, and water on the GI hormone response - GLP-1
Time Frame: 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)
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Plasma GLP-1 will be measured with a commercially available immunoassay kit (MILLIPLEX® MAP; Millipore Corporation, Billerica, MA, USA).
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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)
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Effect of sucrose, glucose, fructose, and water on the GI hormone response - PYY
Time Frame: 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).
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PYY-3-36 will be quantified using a non-radioactive high sensitive sandwich ELISA (Millipore - # EZHPYYT66K).
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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).
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Effect of sucrose, glucose, fructose, and water on the GI hormone response - CCK
Time Frame: 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).
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Plasma cholecystokinin (CCK) levels will be measured with a sensitive radioimmunoassay using a highly specific antiserum (No. 92128)
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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).
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Effect of sucrose, glucose, fructose, and water on the GI hormone response - Ghrelin
Time Frame: 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).
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Octanoylated ghrelin will be measured by a radioimmunoassay with 125I [Tyr24] human ghrelin as tracer and a rabbit antibody against human ghrelin (final dilution 1/100000), which does not cross-react with desoctanoylated ghrelin.
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Effects on glycemic control - plasma glucose
Time Frame: 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).
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Glucose will be measured by a glucose oxidase method (Rothen Medizinische Laboratorien AG, Basel, Switzerland).
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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).
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Effects on glycemic control - plasma insulin
Time Frame: 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).
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Insulin will be quantified using a chemiluminescent microparticle immunoassay (chemiflex) reagent kit (#8k41; Abbott) and the relative light units detected by the ARCHITECT optical system (model: CI4100; Abbott).
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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).
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Effects on glycemic control - plasma c-peptide
Time Frame: 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).
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C-peptide will be measured with a commercially available sandwich ELISA kit from Millipore (Millipore - # EZHCP-20K).
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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).
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Effects on glycemic control - plasma glucagon
Time Frame: 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).
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Glucagon concentrations in plasma will be measured after extraction of plasma with 70% ethanol (vol/vol, final concentration).
The antibody is directed against the C-terminus of the glucagon molecule (antibody code no.
4305) and therefore mainly measures glucagon of pancreatic origin.
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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).
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Effects on erythritol concentrations
Time Frame: 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).
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Erythritol concentrations will be measured by GC-MS/MS (Gas Chromatography Tandem Mass Spectrometry).
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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).
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Effects on xylitol concentrations
Time Frame: 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).
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Xylitol concentrations will be measured by GC-MS/MS (Gas Chromatography Tandem Mass Spectrometry).
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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).
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Effects on blood coagulation function - p-selectin
Time Frame: 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).
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Plasma concentrations of p-selectin will be measured using a commercially available ELISA-kit.
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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).
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Effects on blood coagulation function - sVCAM1
Time Frame: 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).
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Plasma concentrations ofsVCAM1 will be measured using a commercially available ELISA-kit.
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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).
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Effects on blood coagulation function - PF-4
Time Frame: 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).
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Plasma concentrations of PF-4 will be measured using a commercially available ELISA-kit.
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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).
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Effects on blood coagulation function - D-Dimers
Time Frame: 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).
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D-Dimers will be measured using an antigen-test.
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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).
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Effects on blood lipids
Time Frame: 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).
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Analyses of blood lipids are carried out in the hospital laboratory.
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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).
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Effects on uric acid
Time Frame: 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).
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Analyses of uric acid are carried out in the hospital laboratory.
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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).
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Effects on hsCRP
Time Frame: Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120, and 180minutes (after administration).
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Concentrations of hsCRP will be measured by Rothen Laboratory in Basel.
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Blood will be drawn at the following time points: -10 and -1 minutes (before administration) and 30, 60, 90, 120, and 180minutes (after administration).
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Effects on gastric emptying rate
Time Frame: 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).
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Gastric emptying rate will be determined using a 13C-sodium acetate breath test.
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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).
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Effects on appetite-related sensations
Time Frame: 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).
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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.
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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).
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Effects on GI tolerance
Time Frame: GI tolerance will be recorded atthe following time points: -10 minutes (before administration) and 30, 60, 90,120, 180, and 240 minutes (after administration).
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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.
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GI tolerance will be recorded atthe following time points: -10 minutes (before administration) and 30, 60, 90,120, 180, and 240 minutes (after administration).
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Collaborators and Investigators
Investigators
- Principal Investigator: Anne Christin Meyer-Gerspach, PD, PhD, St. Clara Research Ltd.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SuGluFru
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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