NCT02384551

Brief Summary

4-Arm Diet Intervention Investigating Effects of Dietary Carbohydrate Type and Amount on gastroesophageal pH, gastroesophageal reflux disease (GERD) symptoms and medication use.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

January 25, 2016

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

6.4 years

First QC Date

March 4, 2015

Results QC Date

May 24, 2023

Last Update Submit

August 27, 2024

Conditions

Gastroesophageal Reflux DiseaseObesity

Keywords

GERDdietcarbohydrateobesity

Outcome Measures

Primary Outcomes (1)

  • Gastroesophageal pH

    ambulatory ph monitoring for percent time gastroesophageal ph \< 4 in 24 hrs

    24 hours

Secondary Outcomes (2)

  • Gastroesophageal Reflux Disease Questionnaire (GERDQ) Score

    9 weeks

  • Gastroesophageal Scale Assessment Symptom (GSAS) Score

    9 weeks

Study Arms (4)

HTHS

ACTIVE COMPARATOR

High total carbohydrate with high total simple carbohydrate diet

Other: Dietary Carbohydrate

HTLS

EXPERIMENTAL

High total carbohydrate with low total simple carbohydrate diet

Other: Dietary Carbohydrate

LTHS

EXPERIMENTAL

Low total carbohydrate with high total simple carbohydrate diet

Other: Dietary Carbohydrate

LTLS

EXPERIMENTAL

Low total carbohydrate with low total simple carbohydrate diet

Other: Dietary Carbohydrate

Interventions

Dietary CarbohydrateOTHER

9 week menu of dietary carbohydrate modification

HTHSHTLSLTHSLTLS

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 or over BMI 30-39.9 GERD

You may not qualify if:

  • History of type 1 diabetes
  • Hernia or strictures
  • Gastroparesis
  • Extra-esophageal GERD
  • Barrett's esophagus or Esophageal adenocarcinoma
  • History of gastric or bariatric or esophageal surgery, radiation or cancer
  • History of gastrointestinal malabsorption
  • Alcohol averaging \> 2 drinks per day during past 3 months
  • Pregnancy / Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

Related Publications (1)

  • Gu C, Olszewski T, King KL, Vaezi MF, Niswender KD, Silver HJ. The Effects of Modifying Amount and Type of Dietary Carbohydrate on Esophageal Acid Exposure Time and Esophageal Reflux Symptoms: A Randomized Controlled Trial. Am J Gastroenterol. 2022 Oct 1;117(10):1655-1667. doi: 10.14309/ajg.0000000000001889. Epub 2022 Jun 21.

    PMID: 35973185RESULT

MeSH Terms

Conditions

Gastroesophageal RefluxObesity

Interventions

Dietary Carbohydrates

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Heidi J Silver
Organization
VA ORD
heidi.j.silver@vumc.org
615-875-9355

Study Officials

  • Kevin D Niswender, MD PhD

    Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 10, 2015

Study Start

January 25, 2016

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Data will be provided as group data upon publication

Locations

US(1)