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OpenTrials
Completed

NCT Number: NCT05182190

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Iowa State University, Food Science and Human Nutrition Department

Ames, Iowa, 50011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

White Bread

Dietary Supplement

Toasted white bread

Black beans whole boiled

Dietary Supplement

Whole boiled black beans with spaghetti sauce

Knife Mill pasta

Dietary Supplement

Black bean pasta (KM) with spaghetti sauce

Combo Flour Pasta

Dietary Supplement

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

Cyclone Flour Pasta

Dietary Supplement

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

Primary outcomes

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

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

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

Secondary outcomes

  1. Change in satiety sensation

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

    Satiety level measured using a visual analog scale (0-100) every 30 minutes postprandially. A higher score indicates greater satiety.

Sponsors and collaborators

Lead sponsor

Iowa State University

Other

Collaborators

  • USDA Beltsville Human Nutrition Research Center

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2022
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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