NCT05182190

Brief Summary

The study purpose is to determine the effect of eating three (3) different pasta flour formulations made from 100% black beans (Zenith) in a meal matrix (spaghetti sauce) on postprandial glycemic response in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 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

Study Start

First participant enrolled

July 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
Last Updated

January 10, 2022

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

December 20, 2021

Last Update Submit

December 20, 2021

Conditions

Keywords

glucoseinsulinlegumes

Outcome Measures

Primary Outcomes (1)

  • Change in baseline blood glucose over 3 hours (glycemic response)

    Venous blood samples were collected via venous catheter. Whole blood samples were analyzed for glucose content and insulin at commercial laboratory.

    Time 0 (fasting) then every 30 minutes for 3 hours

Secondary Outcomes (1)

  • Change in satiety sensation

    Time 0 (fasting) then every 30 minutes for 3 hours

Study Arms (5)

Control - White bread

ACTIVE COMPARATOR

Commercial white bread in a 50 gram available carbohydrate dose

Dietary Supplement: White bread

Control - whole black beans

ACTIVE COMPARATOR

Whole boiled black beans (Zenith) in a 50 gram available carbohydrate dose

Dietary Supplement: Black beans whole boiled

Knife Mill pasta

EXPERIMENTAL

Heat treated black bean flour made with standard Knife Mill techniques

Dietary Supplement: Knife Mill pasta

Combined pasta

EXPERIMENTAL

Black bean flour with medium protein made with novel compression/decompression mill

Dietary Supplement: Combo Flour Pasta

Cyclone pasta

EXPERIMENTAL

Black bean flour with lower protein made with novel compression/decompression mill

Dietary Supplement: Cyclone Flour Pasta

Interventions

White breadDIETARY_SUPPLEMENT

Toasted white bread

Control - White bread
Black beans whole boiledDIETARY_SUPPLEMENT

Whole boiled black beans with spaghetti sauce

Control - whole black beans
Knife Mill pastaDIETARY_SUPPLEMENT

Black bean pasta (KM) with spaghetti sauce

Knife Mill pasta
Combo Flour PastaDIETARY_SUPPLEMENT

Black bean pasta (Combo) with spaghetti sauce (medium protein flour)

Combined pasta
Cyclone Flour PastaDIETARY_SUPPLEMENT

Black bean pasta (Cyclone) with spaghetti sauce (low protein flour)

Cyclone pasta

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal blood glucose
  • BMI between 20-29.9 kg/m2.
  • Chronic health conditions, e.g., hypertension, gastrointestinal disease.

You may not qualify if:

  • Weight changes of \>10% of body weight within previous 6 months
  • Pregnant or breastfeeding
  • Allergy to peas, beans, lentils, tomatoes, gluten, or latex
  • Unwillingness or inability to follow study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University, Food Science and Human Nutrition Department

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 5 x 5 crossover study with 3 treatments and two controls
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Food Science and Human Nutrition

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 10, 2022

Study Start

July 10, 2019

Primary Completion

February 29, 2020

Study Completion

March 15, 2020

Last Updated

January 10, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations