Mass Balance of Orally Administered [14C] (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one

NCT06230900 | Completed

• 1 other identifier: NL84060.028.23
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Energy Intake; Energy Metabolism

Outcome Measures

Primary Outcomes (1)

• 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

  day 0-3 test period

Secondary Outcomes (7)

• 14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one elimination routes

  day 0-3 test period

• Metabolite profiling of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites

  day 0-3 test period

• Quantification of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites

  day 0-3 test period

• Structural identification of (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one metabolites

  day 0-3 test period

• Resting energy expenditure

  day 0-3 test period

Study Arms (1)

Experimental group

EXPERIMENTAL

14C (3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion (test period)

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

Interventions

(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one OTHER

(3S,4S,5R)-1,3,4,5,6-pentahydroxy-hexan-2-one ingestion

Experimental group

14C-(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 ingestion

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \<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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wageningen University: lead
• TNO: collaborator
• Bonumose, Inc.: collaborator
• Gelderse Vallei Hospital: collaborator

Study Sites (1)

Wageningen University and Research

Wageningen, Gelderland, 6708PB, Netherlands

Location

Study Officials

• Marlou Dirks, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 30, 2024
• Study Start: February 5, 2024
• Primary Completion: April 19, 2025
• Study Completion: April 19, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

NL (1)