NCT02938065

Brief Summary

The proposed study will use this technology to observe emptying of the stomach of a protein and carbohydrate rich clear liquid sports/nutrition drink.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

July 25, 2016

Last Update Submit

August 21, 2017

Conditions

Gastric Emptying

Outcome Measures

Primary Outcomes (2)

  • Measurement of rate of gastric emptying through measure of the gastric antral cross-sectional area (CSA)

    Participants will be followed up to 6 hours after drinking 10 ounces of beverage

  • Subjective evolution of hunger after ingestion of clear fluids using a validated visual analog scale called the Hunger Satiety Score

    Participants will be followed up to 6 hours after drinking 10 ounces of beverage

Study Arms (3)

2% Milk

OTHER

16 participants will drink 10 ounces of 2% milk Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach

Procedure: UltrasoundOther: 2% milk

Apple Juice

OTHER

16 participants will drink 10 ounces of apple juice Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach

Procedure: UltrasoundOther: apple juice

Ensure Clear

OTHER

16 participants will drink 10 ounces of ensure clear Ultrasound scan will be performed at the time of beverage administration and then every 30 minutes thereafter until beverage has been cleared from the stomach

Procedure: UltrasoundOther: ensure clear

Interventions

UltrasoundPROCEDURE

Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.

2% MilkApple JuiceEnsure Clear
2% milkOTHER

16 participants will drink 10 ounces of 2% milk

2% Milk
apple juiceOTHER

16 participants will drink 10 ounces of apple juice

Apple Juice
ensure clearOTHER

16 participants will drink 10 ounces of ensure clear

Ensure Clear

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • Willing to not eat or drink for at least 8 hours overnight beforehand
  • Have a BMI \< 35

You may not qualify if:

  • Use tobacco of any kind
  • Taking any medications (Females: oral contraceptives okay)
  • Suffers from diabetes, Crohn's Disease, Celiac Disease, Malabsorption, Galactosemia
  • Has ever has surgery on esophagus, stomach, or small bowel
  • Has allergies or intolerances to milk, apple juice, or ensure clear
  • Has any surgical condition, disease, or on any medication that could alter stomach emptying rate
  • Has any disease that limits day-to-day activities
  • Is pregnant or possibly could be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Related Publications (1)

  • Du T, Hill L, Ding L, Towbin AJ, DeJonckheere M, Bennett P, Hagerman N, Varughese AM, Pratap JN. Gastric emptying for liquids of different compositions in children. Br J Anaesth. 2017 Nov 1;119(5):948-955. doi: 10.1093/bja/aex340.

    PMID: 29077812DERIVED

MeSH Terms

Interventions

High-Energy Shock WavesMilk

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Jayant Pratap, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Trung Du, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

October 19, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

US(1)