Metabolic Effects of Pulse Consumption on Biomarkers in Adults With Type 2 Diabetes or Met Syn

Study Overview
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Brief Summary
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The purpose of this study is to determine glycemic response of four different meals containing either whole green peas, whole lentils, powdered green peas, or powdered lentils in comparison to Glucola. Participants are adults with type 2 diabetes mellitus or metabolic syndrome.

Detailed Description
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The 5 test treatments (Glucola, whole green peas, green pea flour, whole lentils, and lentil flour) will be administered randomly over five weeks. The test Participants will be required to consume the entire test treatment meal in 12 minutes while being observed. Venous blood samples will be collected for blood glucose and insulin levels 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 finishes consuming the treatment meal). During the first visit blood was drawn for a lipid panel and HbA1C values. Thyroid stimulating hormone (TSH) and complete blood count (CBC) values were analyzed during the second visit, and vitamin D levels analyzed during the final visit. 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. Test meal and blood glucose results at the 5 test points were entered into SPSS statistical software (V. 25) for data cleaning and analysis. Physical activity and the 24 hour dietary recall data were used to classify individuals on activity and dietary quality. Satiety responses were compared against each of the 5 test meals for each participant as well as the gastrointestinal responses using SPSS.

Official Title
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Metabolic Effects of Pulse Consumption on Biomarkers in Adults With Type 2 Diabetes Mellitus or Metabolic Syndrome

Conditions
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Type2 Diabetes Mellitus, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Glucola
* Dietary Supplement: Whole pea meal
* Dietary Supplement: Pea flour meal
* Dietary Supplement: Whole lentils
* Dietary Supplement: Lentil flour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 24-70 years BMI between 22-40 Medical diagnosis of type 2 diabetes HbA1C <10%) OR have 3+ indicators of metabolic syndrome (high triglycerides, low HDL-cholesterol, high blood pressure) plus prediabetes HbA1c. Exclusion Criteria: Uncontrolled hypertension or other health issues, e.g., gastrointestinal disease Weight changes of >10% of participants body weight within a 6 month period Pregnant or breastfeeding Allergy to peas, lentils, tomatoes, gluten, or latex HgbA1c level of >10% at screening Unwillingness or inability to follow study protocol.

Ages Eligible for Study
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Minimum Age: 24 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 4 treatments and one control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control - Glucola<br>Glucola control beverage | Dietary Supplement: Glucola<br>* 50 grams of Glucola sugar beverage<br>|
| Experimental: Whole peas<br>Whole cooked peas in a 50 gram carbohydrate meal dose | Dietary Supplement: Whole pea meal<br>* Whole cooked peas with spaghetti sauce and a slice of bread.<br>|
| Experimental: Pea Flour<br>Pea flour in a 50 gram carbohydrate meal dose | Dietary Supplement: Pea flour meal<br>* Pea flour with spaghetti sauce and a slice of bread.<br>|
| Experimental: Whole lentils<br>Whole cooked lentils in a 50 gram carbohydrate meal dose | Dietary Supplement: Whole lentils<br>* Whole cooked lentils with spaghetti sauce and a slice of bread.<br>|
| Experimental: Lentil flour<br>Lentil flour in a 50 gram carbohydrate meal dose | Dietary Supplement: Lentil flour<br>* Lentil flour with spaghetti sauce and a slice of bread.<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 Quest Diagnostics. | Time 0 (fasting) then every 30 minutes for 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastrointestinal symptoms | Gastrointestinal concerns and changes were noted on a descriptive questionnaire | 3 hours postprandial, and 12 hours postprandial | 
| 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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Glycemic response, Glucose, Type 2 diabetes, Legumes, Metabolic Syndrome