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

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

Interventions

OTHER

(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

COMBINATION_PRODUCT

14C-(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 ingestion

Sponsors & Collaborators

• TNO

  collaborator OTHER

• Bonumose, Inc.

  collaborator UNKNOWN

• Gelderse Vallei Hospital

  collaborator OTHER

• Wageningen University

  lead OTHER

Principal Investigators

• Marlou Dirks, PhD · Principal Investigator

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-05

Primary Completion

2025-04-19

Completion

2025-04-19

Countries

• Netherlands

Study Locations