Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults

Study Overview
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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.

Official Title
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Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults

Conditions
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Glucose, High Blood

Intervention / Treatment
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* 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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 5 x 5 crossover study with 3 treatments and two controls
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose, insulin, legumes