Energy IntakeTrueCalNCT06230900
Mass Balance of Orally Administered [14C] (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one
A study testing (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one and 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one in people with Energy Intake and Energy Metabolism, run by Wageningen University at 1 site in Netherlands.
Trial summary
Worldwide almost 40% of the adult population is overweight (including >10% obese), and more than 350 million children (up to the age of 19) are overweight. Overweight and obesity are significant problems and important risk factors for several lifestyle-related diseases, such as cardiovascular disease, certain cancers… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Intake, Energy Metabolism
- What is being tested?
- (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one and 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Feb 2024to 19 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females using contraception during and for 3 months after the study, aged from 18-65 years at the time of signing the informed consent
- 18.5<BMI<25kg.m2
- Willing and able to communicate and participate in the whole study, including consumption of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one and meals offered during study conduct
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
- Usually eat 3 meals per day (i.e. breakfast, lunch and dinner)
Who cannot join
- Any diagnosed metabolic Impairment (e.g. Type 1 or 2 diabetes)
- Any diagnosed cardiovascular disease
- Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastro-intestinal disease, immunodeficiency, endocrine, neurological or psychiatric disorders
- Any diagnosed respiratory disease, such as COPD or asthma
- Any previous motor disorders or disorders in muscle and/or lipid metabolism
Show all 29Show fewer
- Known severe kidney problems
- Presence of an ulcer in the stomach or gut and/or strong history of indigestion
- Recent or chronic history of diarrhoea
- Known anaemia
- A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia.
- Regular use of dietary supplements (>3 times per week)
- Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
- History of any drug or alcohol abuse in the past two years
- Drug use
- Claustrophobia
- On a weight loss diet (including intermittent fasting) or following a high calorific/high protein diet in order to gain weight
- Functional constipation
- Any known food allergies or intolerances to the 14 major food allergens (celery, cereals containing gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, tree nuts, peanuts, sesame seeds, soybeans, sulphur dioxide and sulphites) or history of a malabsorption syndrome including coeliac disease
- Regular gastrointestinal complaints including abdominal pain, stomach upsets and borborygmi or known or suspected irritable bowel syndrome
- Currently taking part in other scientific research
- Received a product with 14C in the past 12 months
- Pregnant or breastfeeding
- Smoking or having used nicotine-containing products in the 6 months prior to the study.
- Taken antibiotics within the 60 days prior to the adaptation period.
- Currently involved in a structured progressive resistance training programme (>3 times per week)
- Sedentary lifestyle as assessed using the International Physical Activity Questionnaire [IPAQ].
- Employed or undertaking a thesis or internship at the department of Human and Animal Physiology or TNO (department of Metabolic Health Research)
- Unable to give consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University and Research
Wageningen, Gelderland, 6708PB
About this study
Official title: Assessment of Mass Balance of Orally Administered [14C] (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one in Healthy Volunteers Using a Microtracer Approach
Worldwide almost 40% of the adult population is overweight (including >10% obese), and more than 350 million children (up to the age of 19) are overweight. Overweight and obesity are significant problems and important risk factors for several lifestyle-related diseases, such as cardiovascular disease, certain cancers, non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2D). Excessive consumption of glucose/sucrose is a major contributor to overweight and obesity. Alternative, low-calorie sweeteners could reduce daily energy intake and thus slow down the development of these conditions and related diseases. (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one is a sweetener that may be suitable for use as a sugar substitute; it is only partially digested in the small intestine and as a result has a lower energy density than more traditional sweeteners such as sucrose. However, it is not yet known to what extent (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one is used in the body and then excreted.
The aim of this study is to measure the metabolic utilization (the 'mass balance') of a single dose of 14C-labelled (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one and AMS technology. Based on clinical data of excretion (urine and faeces) and CO2 production (expired air), the mass balance can be derived. These generated results will be used to map the metabolic pathways (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one undergoes during the digestion process. In addition, it will provide insight into the use of AMS technology to investigate the relationship between diet and health.
Read the detailed description
Objective: To determine the mass balance of (3S,4S,5R)-1,3,4,5,6-Pentahydroxy-hexan-2-one (low GI sweetener) in healthy volunteers.
Study design: Single centre, open-label, non-randomised, single oral administration study Study population: 8 healthy males and females (18-65 y, BMI 18.5-25 kg·m-2) Intervention: Orally ingestion of 14C-labelled (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one, followed by a 72-hour test period during which all urine and faeces will be collected, as well as repeated sampling of blood and expired air, as well as indirect calorimetry measurements.
Main study parameters/endpoints: Mass balance of (3S,4S,5R)-1,3,4,5,6-Pentahydroxy-hexan-2-one following 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion. Secondary endpoints: content of 14C-labelled metabolites in carbohydrate metabolism pathways, routes of elimination of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one. Ventilated hood measurements will be used as proof of concept to assess caloric value of carbohydrates.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Insertion of the catheters in a vein is comparable to a normal blood draw and the only risk is a small local hematoma. (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion might lead to gastro-intestinal discomfort. During the adaptation period participants will consume food-grade (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one, which is safe for human consumption.
- Conditions
- Energy Intake, Energy Metabolism
- Being tested
- (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one, 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-oneOther
(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion
14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-oneCombination product
14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion (test period) Receives: Other: (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one; Combination Product: 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one |
What is being measured
The primary outcome is the main question the study is designed to answer.
14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one mass balance
Mass balance recovery after a single oral dose of 14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one
Measured: day 0-3 test period
Secondary outcomes (7)
14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one elimination routes
Mass balance recovery after a single oral dose of 14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one
Measured: day 0-3 test period
Metabolite profiling of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Plasma, urine and faecal metabolite profiling of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Measured: day 0-3 test period
Quantification of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Plasma, urine and faecal quantification of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Measured: day 0-3 test period
Structural identification of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Plasma, urine and faecal structural identification of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Measured: day 0-3 test period
Resting energy expenditure
REE based on the Weir formula
Measured: day 0-3 test period
(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one pathway activity
(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one pathway activity
Measured: day 0-3 test period
Rate of whole-body substrate oxidation
Rate of whole-body substrate oxidation (i.e. carbohydrate and lipid oxidation) measured via indirect calorimetry
Measured: day 0-3 test period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start5 Feb 2024
- Primary completion19 Apr 2025
- Study completion19 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- TNO, Bonumose, Inc., Gelderse Vallei Hospital
- Responsible party
- Principal investigator, Marlou Dirks, Wageningen University
- Investigators
- Marlou Dirks, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230900
- Sponsor's protocol ID
- NL84060.028.23
- Acronym
- TrueCal
- Status last verified
- Apr 2025
- First submitted
- 7 Jan 2024
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mass Balance of Orally Administered [14C] (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one in Healthy Volunteers Using a Microtracer Approach
- ClinicalTrials.gov ID
- NCT06230900
- Acronym / sponsor ID
- TrueCal / NL84060.028.23
- Conditions
- Energy Intake, Energy Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- TNO, Bonumose, Inc., Gelderse Vallei Hospital
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 19 Apr 2025 (actual)
- Study completion
- 19 Apr 2025 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Worldwide almost 40% of the adult population is overweight (including >10% obese), and more than 350 million children (up to the age of 19) are overweight. Overweight and obesity are significant problems and important risk factors for several lifestyle-related diseases, such as cardiovascular disease, certain cancers, non-alcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2D). Excessive consumption of glucose/sucrose is a major contributor to overweight and obesity. Alternative, low-calorie sweeteners could reduce daily energy intake and thus slow down the development of these conditions and related diseases. (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one is a sweetener that may be suitable for use as a sugar substitute; it is only partially digested in the small intestine and as a result has a lower energy density than more traditional sweeteners such as sucrose. However, it is not yet known to what extent (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one is used in the body and then excreted.
The aim of this study is to measure the metabolic utilization (the 'mass balance') of a single dose of 14C-labelled (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one and AMS technology. Based on clinical data of excretion (urine and faeces) and CO2 production (expired air), the mass balance can be derived. These generated results will be used to map the metabolic pathways (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one undergoes during the digestion process. In addition, it will provide insight into the use of AMS technology to investigate the relationship between diet and health.
Detailed description
Objective: To determine the mass balance of (3S,4S,5R)-1,3,4,5,6-Pentahydroxy-hexan-2-one (low GI sweetener) in healthy volunteers.
Study design: Single centre, open-label, non-randomised, single oral administration study Study population: 8 healthy males and females (18-65 y, BMI 18.5-25 kg·m-2) Intervention: Orally ingestion of 14C-labelled (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one, followed by a 72-hour test period during which all urine and faeces will be collected, as well as repeated sampling of blood and expired air, as well as indirect calorimetry measurements.
Main study parameters/endpoints: Mass balance of (3S,4S,5R)-1,3,4,5,6-Pentahydroxy-hexan-2-one following 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion. Secondary endpoints: content of 14C-labelled metabolites in carbohydrate metabolism pathways, routes of elimination of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one. Ventilated hood measurements will be used as proof of concept to assess caloric value of carbohydrates.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Insertion of the catheters in a vein is comparable to a normal blood draw and the only risk is a small local hematoma. (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion might lead to gastro-intestinal discomfort. During the adaptation period participants will consume food-grade (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one, which is safe for human consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one, Combination Product: 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion (test period) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy males and females using contraception during and for 3 months after the study, aged from 18-65 years at the time of signing the informed consent
- 18.5<BMI<25kg.m2
- Willing and able to communicate and participate in the whole study, including consumption of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one and meals offered during study conduct
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
- Usually eat 3 meals per day (i.e. breakfast, lunch and dinner)
Key exclusion criteria (29 listed)
- Any diagnosed metabolic Impairment (e.g. Type 1 or 2 diabetes)
- Any diagnosed cardiovascular disease
- Hypertension (≥140 mmHg systolic and/or ≥90 mmHg diastolic)
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastro-intestinal disease, immunodeficiency, endocrine, neurological or psychiatric disorders
- Any diagnosed respiratory disease, such as COPD or asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion | Other | Experimental group |
| 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion | Combination product | Experimental group |
Primary outcome
14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one mass balance
Time frame: day 0-3 test period
Mass balance recovery after a single oral dose of 14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one
7 secondary outcomes
14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one elimination routes
Time frame: day 0-3 test period
Metabolite profiling of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Time frame: day 0-3 test period
Quantification of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Time frame: day 0-3 test period
Structural identification of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites
Time frame: day 0-3 test period
Resting energy expenditure
Time frame: day 0-3 test period
(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one pathway activity
Time frame: day 0-3 test period
Rate of whole-body substrate oxidation
Time frame: day 0-3 test period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlou Dirks, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one and 14C-(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one in people with Energy Intake and Energy Metabolism, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one mass balance (time frame: day 0-3 test period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.