The effect of a natural extract on glucose fluxes after consumption of a wheat product

The effect of a natural extract on glucose fluxes after consumption of a wheat product - FDS-NAA-1650

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42790

Enrollment

Registered

2015-12-01

Start date

2016-01-04

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

effect on blood glucose Blood glucose postprandial hyperglycemia

Interventions

Two different investigational treatments will be consumed: * Treatment 1 (P1): A wheat product (containing 2% 13C-universally-labeled wheat) with natural extract added. * Treatment 2 (G): A solution

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent signed. 2. Healthy Caucasian male. 3. Age at start of the study * 20 and * 50 years. 4. Body mass index (BMI) * 18.0 and * 25.0 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1. 2. Reported intense sporting activities > 10h/w. 3. Not being used to eat breakfast.

Design outcomes

Primary

Measure	Time frame
EFFICACY ENDPOINTS: In plasma: 1. 13C- and 2H-enrichment (mo * m6) of glucose (Gas Chromatography/Mass Spectrometry; GC/MS) 2. Total blood glucose (BG) 3. Insulin	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)