Clinical trial NCT05182190: Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults
Official title: Effects of Black Bean Pasta Consumption on Biomarkers in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose, High Blood
Keywords: glucose
insulin
legumes
Lead sponsor: Iowa State University
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2022-01-10
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 5 x 5 crossover study with 3 treatments and two controls
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline blood glucose over 3 hours (glycemic response)
timeFrame: Time 0 (fasting) then every 30 minutes for 3 hours
Secondary outcomes:
measure: Change in satiety sensation
timeFrame: Time 0 (fasting) then every 30 minutes for 3 hours
Other outcomes:
Locations:
city: Ames
country: United States
facility: Iowa State University, Food Science and Human Nutrition Department
state: Iowa
Study officials:
References: