Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230900
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2024-01-07
Brief Title:
Mass Balance of Orally Administered 14C 3S4S5R-13456-pentahydroxy-hexan-2-one
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
Assessment of Mass Balance of Orally Administered 14C 3S4S5R-13456-pentahydroxy-hexan-2-one in Healthy Volunteers Using a Microtracer Approach
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TrueCal
Brief 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 non-alcoholic fatty liver disease NAFLD and type 2 diabetes T2D Excessive consumption of glucosesucrose 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 3S4S5R-13456-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 3S4S5R-13456-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 3S4S5R-13456-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 3S4S5R-13456-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
The aim of this study is to measure the metabolic utilization the mass balance of a single dose of 14C-labelled 3S4S5R-13456-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 3S4S5R-13456-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 3S4S5R-13456-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 185-25 kgm-2 Intervention Orally ingestion of 14C-labelled 3S4S5R-13456-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 parametersendpoints Mass balance of 3S4S5R-13456-Pentahydroxy-hexan-2-one following 14C-3S4S5R-13456-pentahydroxy-hexan-2-one ingestion Secondary endpoints content of 14C-labelled metabolites in carbohydrate metabolism pathways routes of elimination of 3S4S5R-13456-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 3S4S5R-13456-pentahydroxy-hexan-2-one ingestion might lead to gastro-intestinal discomfort During the adaptation period participants will consume food-grade 3S4S5R-13456-pentahydroxy-hexan-2-one which is safe for human consumption
Study design Single centre open-label non-randomised single oral administration study Study population 8 healthy males and females 18-65 y BMI 185-25 kgm-2 Intervention Orally ingestion of 14C-labelled 3S4S5R-13456-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 parametersendpoints Mass balance of 3S4S5R-13456-Pentahydroxy-hexan-2-one following 14C-3S4S5R-13456-pentahydroxy-hexan-2-one ingestion Secondary endpoints content of 14C-labelled metabolites in carbohydrate metabolism pathways routes of elimination of 3S4S5R-13456-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 3S4S5R-13456-pentahydroxy-hexan-2-one ingestion might lead to gastro-intestinal discomfort During the adaptation period participants will consume food-grade 3S4S5R-13456-pentahydroxy-hexan-2-one which is safe for human consumption
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None