Metabolic Effects of Pulse Consumption on Biomarkers in Adults With Type 2 Diabetes or Met Syn
Condition: Type2 Diabetes Mellitus; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Glucola; Whole pea meal; Pea flour meal; Whole lentils; Lentil flour
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 50 grams of Glucola sugar beverage; Whole cooked peas with spaghetti sauce and a slice of bread.; Pea flour with spaghetti sauce and a slice of bread.; Whole cooked lentils with spaghetti sauce and a slice of bread.; Lentil flour with spaghetti sauce and a slice of bread.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 5 x 5 crossover study with 4 treatments and one control
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glycemic response; Glucose; Type 2 diabetes; Legumes; Metabolic Syndrome