NCT06146322

Brief Summary

Novel barley varieties high in the soluble fiber β-glucan have the capacity to improve population health through improving glycemic control. Sweetened and unsweetened wholegrain barley foods were tested in a randomized, controlled, crossover human clinical trial to assess impact on postprandial appetite and food intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

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

October 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

November 17, 2023

Last Update Submit

November 17, 2023

Conditions

Diet, HealthyBlood Sugar; HighDiabetesAppetite and General Nutritional DisordersAppetitive Behavior

Keywords

Beta-glucanFiberGlycemic ControlAppetite

Outcome Measures

Primary Outcomes (3)

  • Postprandial glycemic response

    Blood glucose measured every 15 minutes post-preload ingestion

    4 hours

  • Subjective appetite

    Self-reported appetite measured using Visual Analogue Scale (VAS) every 15 minutes post-preload ingestion

    4 hours

  • Food intake

    Food intake at a 16-item ad libitum test meal served 4 hours post-preload ingestion

    30 minutes

Interventions

WROTHER

Unsweetened preload condition: 240 mL white glutinous rice, 250 kcal, 0 g β-glucan

LBOTHER

Unsweetened preload condition: 240 mL low β-glucan barley, 250 kcal, \~4 g β-glucan

MBOTHER

Unsweetened preload condition: 240 mL medium β-glucan barley, 250 kcal, \~5 g β-glucan

HBOTHER

Unsweetened preload condition: 240 mL high β-glucan barley, 250 kcal, \~6 g β-glucan

WR+50g HFCSOTHER

Sweetened condition with high fructose corn syrup (HFCS): 240 mL white glutinous rice + 50g HFCS, 391 kcal, 0 g β-glucan

LB + 50 g HFCSOTHER

Sweetened condition with high fructose corn syrup (HFCS): 240 mL low β-glucan barley + 50 g HFCS, 391 kcal, \~4 g β-glucan

MB + 50 g HFCSOTHER

Sweetened condition with high fructose corn syrup (HFCS): 240 mL medium β-glucan barley + 50 g HFCS, 391 kcal, \~5 g β-glucan

HB + 50 g HFCSOTHER

Sweetened condition with high fructose corn syrup (HFCS): 240 mL high β-glucan barley + 50 g HFCS, 391 kcal, \~6 g β-glucan

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • Body Mass Index (BMI) values of 18.5-40.0 kg/m2
  • Normal fasting blood glucose (\<100 mg/dL)

You may not qualify if:

  • Use of medications known to be associated with weight change (e.g., beta-blockers)
  • Use of steroid pills or shots such as prednisone or cortisone
  • Use of nicotine
  • Weight change of ten or more pounds in the last three months
  • Major daily variation in physical activity (e.g., athletes in training)
  • History of extensive small bowel surgery or surgery to treat obesity
  • History of heart attack, stroke, or bypass
  • History of cancer within the last five years (exception: non-melanoma skin cancer)
  • Recent or current medical diagnosis or medical treatment that would alter appetite, energy needs, satiety, and/or could impact the results of the trial
  • Medical diagnoses of diabetes, cardiovascular disease, high levels of blood lipids, asthma, cold, and flu (exception: hypertension, if treated with medication prescribed more than three months prior to the screening activity)
  • Fear of blood or needles
  • Dietary restrictions that would interfere with consuming test foods (e.g., gluten intolerance, vegan, corn syrup allergy)
  • Following a weight modification diet
  • Sensitive to food textures present in the test foods
  • Following personal schedules that would not permit attendance at all scheduled testing sessions
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusAppetitive Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehavior

Study Officials

  • Martine Perrigue, PhD, RDN

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Nutrition and Exercise Physiology

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 24, 2023

Study Start

October 1, 2019

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)