Healthy Subjects
Conditions
Keywords
protein-enriched bar, food intake, appetite, satiety related hormones
Brief summary
The aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects.
Detailed description
Twenty healthy subjects will be recruited. Every subject will be randomized in 6 groups and studied on 3 separate days in random order with 1 week intervals. These participants will consume protein enriched bar, commercial cereal bar, or water followed by a standardized diet (gimbap). For study outcomes, food intake, appetite and satiety (visual analog scale), plasma glucose, and satiety related hormone will be measured. Blood sampling will be done before 15 min of breakeast, at the moment of start of breakfast (0 min), and then 30, 60, 90, 120 min. Plasma glucose levels, total/active GLP-1, ghrelin, total PYY will be measured.
Interventions
DIETARY_SUPPLEMENTProtein-enriched bar, commercial cereal bar, or water
Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria: * BMI 18.5\ 35 kg/m2 * Never diagnosed by diabetes * Fasting plasma glucose \<=100mg/dl and HbA1c \<6.0% *
Exclusion criteria
* Those who diagnosed by Type 1 or Type 2 diabetes * Allergy to wheat, flour, nuts, milk * Pregnancy/lactation * AST or ALT \>2.5 times of upper normal reference range * eGFR \<30 mL/min/1.73m2 * Hb \<10g/dl * History of GI surgery (except hemorrhoidectomy, appendectomy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Food intake | 120min | grams and caloric intake of standardized gimbap |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety (visual analogue scale : score 1 to 10) | 120min | — |
| plasma glucose (mmol/L) | -15min, 0(breakfast), 30, 60, 90, 120 min | plasma level of glucose |
| Appetite (visual analogue scale : score 1 to 10) | 120min | (1: I am not hungry at all, 10: I have never been more hungry) |
| plasma active ghrelin (ng/ml) | -15min, 0(breakfast), 30, 60, 90, 120 min | plasma level of active ghrelin |
| plasma total peptide YY (pg/ml) | -15min, 0(breakfast), 30, 60, 90, 120 min | plasma level of peptide YY |
| plasma active/total GLP-1 (pmol/L) | -15min, 0(breakfast), 30, 60, 90, 120 min | plasma level of active/total GLP-1 |
Countries
South Korea
Outcome results
None listed