An Exploratory Study of the Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Food Intake in Healthy Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Food intake
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Group 1
protein enriched bar->commercial cereal bar->water
Intervention: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 2
protein enriched bar->water->commercial cereal bar
Intervention: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 3
commercial cereal bar->protein enriched bar->water
Intervention: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 4
commercial cereal bar->water->protein enriched bar
Intervention: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 5
water->protein enriched bar->commercial cereal bar
Intervention: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Group 6
water->commercial cereal bar->protein enriched bar
Intervention: Protein-enriched bar, commercial cereal bar, or water (Dietary Supplement)
Outcomes
Primary Outcomes
Food intake
Time Frame: 120min
grams and caloric intake of standardized gimbap
Secondary Outcomes
- Satiety (visual analogue scale : score 1 to 10)(120min)
- Appetite (visual analogue scale : score 1 to 10)(120min)
- plasma glucose (mmol/L)(-15min, 0(breakfast), 30, 60, 90, 120 min)
- plasma active/total GLP-1 (pmol/L)(-15min, 0(breakfast), 30, 60, 90, 120 min)
- plasma total peptide YY (pg/ml)(-15min, 0(breakfast), 30, 60, 90, 120 min)
- plasma active ghrelin (ng/ml)(-15min, 0(breakfast), 30, 60, 90, 120 min)
Investigators
Young Min Cho
Professor
Seoul National University Hospital