Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults

NCT ID: NCT05182190

Last Updated: 2022-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-10

Study Completion Date

2020-03-15

Brief Summary

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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.

Detailed Description

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The 5 test treatments (white bread (negative control), whole black beans (positive control), and 3 different pasta formulations) will be administered randomly over five weeks. Meals will be combined with spaghetti sauce for a total available carbohydrate amount of 50g.

Venous blood samples will be collected for glucose and insulin analysis at time 0 (fasting) and at 30, 60, 90, 120, and 180 minutes post-treatment (timing of the post-treatment blood draws started at time 0 \[post-treatment\], which is when the participant starts consuming the treatment meal). Blood analysis was completed by a reputable biomarker diagnostics laboratory, Quest Diagnostics.

Anthropometric measures such as weight, height, waist circumference, and blood pressure were collected at screening and at the start of each test day. Thirteen hours before testing, participants consumed a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes. This control meal was selected by each participant before the start of the study. Each participant was provided the same frozen meal every time, since the subjects serve as their own controls. The day before test day, participants completed a 24 hour food recall, satiety, and gastrointestinal questionnaires. The morning of each test day participants completed the International Physical Activity Questionnaire (IPAQ), satiety, and gastrointestinal questionnaires.

Conditions

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Glucose, High Blood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

5 x 5 crossover study with 3 treatments and two controls
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control - White bread

Commercial white bread in a 50 gram available carbohydrate dose

Group Type ACTIVE_COMPARATOR

White bread

Intervention Type DIETARY_SUPPLEMENT

Toasted white bread

Control - whole black beans

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

Group Type ACTIVE_COMPARATOR

Black beans whole boiled

Intervention Type DIETARY_SUPPLEMENT

Whole boiled black beans with spaghetti sauce

Knife Mill pasta

Heat treated black bean flour made with standard Knife Mill techniques

Group Type EXPERIMENTAL

Knife Mill pasta

Intervention Type DIETARY_SUPPLEMENT

Black bean pasta (KM) with spaghetti sauce

Combined pasta

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

Group Type EXPERIMENTAL

Combo Flour Pasta

Intervention Type DIETARY_SUPPLEMENT

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

Cyclone pasta

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

Group Type EXPERIMENTAL

Cyclone Flour Pasta

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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White bread

Toasted white bread

Intervention Type DIETARY_SUPPLEMENT

Black beans whole boiled

Whole boiled black beans with spaghetti sauce

Intervention Type DIETARY_SUPPLEMENT

Knife Mill pasta

Black bean pasta (KM) with spaghetti sauce

Intervention Type DIETARY_SUPPLEMENT

Combo Flour Pasta

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

Intervention Type DIETARY_SUPPLEMENT

Cyclone Flour Pasta

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role collaborator

Iowa State University

OTHER

Sponsor Role lead

Responsible Party

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Donna Winham

Assistant Professor, Food Science and Human Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Iowa State University, Food Science and Human Nutrition Department

Ames, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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17-191BB

Identifier Type: -

Identifier Source: org_study_id

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