Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults

Glucose, High Blood Clinical Trial

Official title:

Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05182190
• Other study ID #: 17-191BB
• Status: Completed
• Phase: N/A
• Start date: July 10, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: December 2021
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 15, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose, High Blood
• Hyperglycemia

Intervention

Dietary Supplement:
• White bread
Toasted white bread
• Black beans whole boiled
Whole boiled black beans with spaghetti sauce
• Knife Mill pasta
Black bean pasta (KM) with spaghetti sauce
• Combo Flour Pasta
Black bean pasta (Combo) with spaghetti sauce (medium protein flour)
• Cyclone Flour Pasta
Black bean pasta (Cyclone) with spaghetti sauce (low protein flour)

Locations

Country	Name	City	State
United States	Iowa State University, Food Science and Human Nutrition Department	Ames	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Iowa State University	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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