Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults

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.

Study Overview

• Status: Completed
• Conditions: Glucose, High Blood
• Intervention / Treatment: Dietary supplement: White bread; Dietary supplement: Black beans whole boiled; Dietary supplement: Knife Mill pasta; Dietary supplement: Combo Flour Pasta; Dietary supplement: Cyclone Flour Pasta

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Ames, Iowa, United States, 50011
      • Iowa State University, Food Science and Human Nutrition Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control - White bread; Commercial white bread in a 50 gram available carbohydrate dose	Dietary supplement: White bread; Toasted white bread
ACTIVE_COMPARATOR: Control - whole black beans; Whole boiled black beans (Zenith) in a 50 gram available carbohydrate dose	Dietary supplement: Black beans whole boiled; Whole boiled black beans with spaghetti sauce
EXPERIMENTAL: Knife Mill pasta; Heat treated black bean flour made with standard Knife Mill techniques	Dietary supplement: Knife Mill pasta; Black bean pasta (KM) with spaghetti sauce
EXPERIMENTAL: Combined pasta; Black bean flour with medium protein made with novel compression/decompression mill	Dietary supplement: Combo Flour Pasta; Black bean pasta (Combo) with spaghetti sauce (medium protein flour)
EXPERIMENTAL: Cyclone pasta; Black bean flour with lower protein made with novel compression/decompression mill	Dietary supplement: Cyclone Flour Pasta; Black bean pasta (Cyclone) with spaghetti sauce (low protein flour)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in satiety sensation	Satiety level measured using a visual analog scale (0-100) every 30 minutes postprandially. A higher score indicates greater satiety.	Time 0 (fasting) then every 30 minutes for 3 hours

Collaborators and Investigators

• Sponsor: Iowa State University
• Collaborators: USDA Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 10, 2019
• Primary Completion (ACTUAL): February 29, 2020
• Study Completion (ACTUAL): March 15, 2020

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (ACTUAL): January 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: insulin; glucose; legumes
• Other Study ID Numbers: 17-191BB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No