The Effect of 40gr Okara on Gastric Emptying
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- To investigate the influence of 40 gram Okara on gastric emptying
Study Overview
Brief Summary
The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)
Detailed Description
This trail will be a single blinded, cross-over design. The study population will include 10 subjects. The patients will be randomly assigned to receive one of two Muffin cakes, with or without 40 grams Okara on three occasions (three visits). In two visits the subject will receive a Muffin cake with 40 grams Okara (but with similar caloric value), and in one visit a Muffin cake without Okara.
Postprandial gastric emptying time will be measured for each subject, by 13C Breath Test.
Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Single
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Healthy volunteers
- •Age 20-65 years old
- •Written Informed Consent
Exclusion Criteria
- •History of gastro-intestinal surgery
- •On medication that may influence gastric emptying, or medication for weight loss
- •Patient on PPI treatment, H2 Blockers or medication for weight loss
- •Known allergies to soy
- •Pregnancy or breast-feeding
- •Metabolic syndrome or diabetes mellitus
- •Family history of metabolic syndrome or diabetes mellitus
- •Weight loss > 2 kg during two months before the study
Outcomes
Primary Outcomes
To investigate the influence of 40 gram Okara on gastric emptying
Secondary Outcomes
No secondary outcomes reported