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Completed

NCT Number: NCT03431233

Effect of Premeal Protein-bar on Food Intake

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

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Key information

Conditions

Healthy Subjects

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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)

Treatment and study plan

Protein-enriched bar, commercial cereal bar, or water

Dietary Supplement

Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.

Primary outcomes

  1. Food intake

    Time frame: 120min

    grams and caloric intake of standardized gimbap

Secondary outcomes

  1. Appetite (visual analogue scale : score 1 to 10)

    Time frame: 120min

    (1: I am not hungry at all, 10: I have never been more hungry)

  2. Satiety (visual analogue scale : score 1 to 10)

    Time frame: 120min

  3. plasma glucose (mmol/L)

    Time frame: -15min, 0(breakfast), 30, 60, 90, 120 min

    plasma level of glucose

  4. plasma active/total GLP-1 (pmol/L)

    Time frame: -15min, 0(breakfast), 30, 60, 90, 120 min

    plasma level of active/total GLP-1

  5. plasma active ghrelin (ng/ml)

    Time frame: -15min, 0(breakfast), 30, 60, 90, 120 min

    plasma level of active ghrelin

  6. plasma total peptide YY (pg/ml)

    Time frame: -15min, 0(breakfast), 30, 60, 90, 120 min

    plasma level of peptide YY

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

An Exploratory Study of the Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Food Intake in Healthy Subjects

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2018
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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