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Assessment of Mass Balance of Orally Administered [14C] Tagatose in Healthy Volunteers Using a Microtracer Approach

Assessment of Mass Balance of Orally Administered [14C] Tagatose in Healthy Volunteers Using a Microtracer Approach - TrueCal

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53253
Enrollment
8
Registered
2023-11-27
Start date
2024-02-05
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolisme Obesity

Interventions

A single test day during which participants will orally ingest a dietary supplement containing 14C-labelled tagatose, followed by a 72-hour test period during which all urine and faeces will be coll

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 18-65 years old healthy female and male using contraception during and for 3 months after the study - BMI 18.5-25 kg/m2 - Must be willing and able to communicate and participate in the whole study, including consumption of tagatose and meals offered during study conduct - Must have regular bowel movements (i.e. average stool production of >=1 and

Exclusion criteria

Exclusion criteria: - Diabetes (Type 1, Type 2, or genetic form of diabetes) - Any diagnosed cardiovascular (heart) disease or high blood pressure (>=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 - A confirmed positive alcohol breath test at screening or admission - Drug use - Claustrophobia - Subjects who are on a weight loss diet or following a high calorific/high protein diet in order to gain weight - Subjects with 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 - Subjects who have regular gastrointestinal complaints including abdominal pain, stomach upsets and borborygmi or known or suspected irritable bowel syndrome - Currently taking part in other scientific research - Having received a product with 14C in the past 12 months - Pregnant or breastfeeding - Smoking or having used nicotin-containing products in the 6 months prior to the study. - Subjects who have 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 - Unable to give consent.

Design outcomes

Primary

MeasureTime frame
72h mass balance following 14C-tagatose ingestion.

Secondary

MeasureTime frame
Secondary endpoints: content of 14C-labelled metabolites in carbohydrate metabolism pathways, whole-body substrate (carbohydrate and lipid) oxidation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026