The Effect of a Natural Extract on Glucose Fluxes After Consumption of a Wheat Product

Unilever

Status: Completed

Conditions: Healthy

Treatments: Other: Glucose solution; Dietary Supplement: Natural fruit extract; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02662738

FDS-NAA-1650

Details and patient eligibility

About

This study is to quantify the effect of a natural fruit extract added to a wheat product on the time needed to absorb 50% of the apparent total of available exogenous carbohydrate (RaE * Time). In addition the different glucose fluxes will be quantified (RaE, EGP and GCR)

Enrollment: 12 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Caucasian male.
• Body mass index (BMI) ≥ 18.0 and ≤ 25.0 kg/m2.
• Apparently healthy: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
• Fasting blood glucose value of volunteer is ≥ 3.4 and ≤ 6.1 mmol/liter (i.e. 62- 110 mg/dl) at screening.
• HbA1c ≤ 6.5 % (48 mmol/mol).

Exclusion criteria

• Use of antibiotics within 3 months before Day 1; use of any other medication except paracetamol within 14 days before Day 1.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 3 patient groups, including a placebo group

A wheat product

Active Comparator group

Description:

A wheat product (containing 2% 13C-universally-labeled wheat) with natural fruit extract added.

Treatment:

Dietary Supplement: Natural fruit extract

Control

Placebo Comparator group

Description:

A wheat product (containing 2% 13C-universally-labeled wheat) without natural fruit extract added.

Treatment:

Other: Placebo

Glucose solution

Other group

Description:

A solution of 50g glucose of which 2% 13C-universally-labeled glucose (2%) and unlabeled glucose (98%) in 250 mL water.

Treatment:

Other: Glucose solution