NCT01678742

Brief Summary

The aim of our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

August 25, 2012

Last Update Submit

March 31, 2015

Conditions

Diabetes MellitusObesity

Keywords

DietIncretinsGastrointestinal HormonesFish Proteins

Outcome Measures

Primary Outcomes (1)

  • Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

    3 hours

Secondary Outcomes (4)

  • Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups

    3 hours

  • Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups

    3 hours

  • Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups

    3 hours

  • Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups

    3 hours

Other Outcomes (4)

  • Difference in the iAUC for glucose after food ingestion between high-protein and standard diet groups

    3 hours

  • Difference in the iAUC for insulin after food ingestion between high-protein and standard diet groups

    3 hours

  • Difference in the iAUC for C-peptide after food ingestion between high-protein and standard diet groups

    3 hours

  • +1 more other outcomes

Study Arms (2)

High-protein diet

EXPERIMENTAL
Dietary Supplement: High-protein diet

Standard diet

ACTIVE COMPARATOR
Dietary Supplement: Standard diet

Interventions

High-protein dietDIETARY_SUPPLEMENT

The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal. A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea.

Also known as: A Jeju red horsehead fish-based meal
High-protein diet
Standard dietDIETARY_SUPPLEMENT

The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.

Also known as: A mixed meal
Standard diet

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus
  • Subjects signed a written informed consent form

You may not qualify if:

  • Liver cirrhosis
  • Chronic renal disease (serum creatinine \> 2mg/dL)
  • Severe congestive heart failure
  • Significant infectious or inflammatory diseases
  • intractable malignant neoplasm
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jeju National University Hospital

Jeju City, 690-767, South Korea

Location

MeSH Terms

Conditions

Diabetes MellitusObesity

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Gwanpyo Koh, Professor

    Jeju National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

August 25, 2012

First Posted

September 5, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations

KR(1)