Effect of Premeal Protein-bar on Food Intake

Seoul National University

Status: Completed

Conditions: Healthy Subjects

Treatments: Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Study type: Interventional

Funder types: Other

Identifiers

NCT03431233

H-1705-091-855

Details and patient eligibility

About

The aim of this study is to explore premeal protein-enriched bar effect in food intake in healthy subjects.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 6 patient groups

Group 1

Experimental group

Description:

protein enriched bar-\>commercial cereal bar-\>water

Treatment:

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 2

Experimental group

Description:

protein enriched bar-\>water-\>commercial cereal bar

Treatment:

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 3

Experimental group

Description:

commercial cereal bar-\>protein enriched bar-\>water

Treatment:

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 4

Experimental group

Description:

commercial cereal bar-\>water-\>protein enriched bar

Treatment:

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 5

Experimental group

Description:

water-\>protein enriched bar-\>commercial cereal bar

Treatment:

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water

Group 6

Experimental group

Description:

water-\>commercial cereal bar-\>protein enriched bar

Treatment:

Dietary Supplement: Protein-enriched bar, commercial cereal bar, or water