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

Iowa State University

Status: Completed

Conditions: Type2 Diabetes Mellitus; Metabolic Syndrome

Treatments: Dietary Supplement: Pea flour meal; Dietary Supplement: Lentil flour; Dietary Supplement: Glucola; Dietary Supplement: Whole lentils; Dietary Supplement: Whole pea meal

Study type: Interventional

Funder types: Other

Identifiers

NCT05145998

17-191

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 24 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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19 participants in 5 patient groups

Control - Glucola

Active Comparator group

Description:

Glucola control beverage

Treatment:

Dietary Supplement: Glucola

Whole peas

Experimental group

Description:

Whole cooked peas in a 50 gram carbohydrate meal dose

Treatment:

Dietary Supplement: Whole pea meal

Pea Flour

Experimental group

Description:

Pea flour in a 50 gram carbohydrate meal dose

Treatment:

Dietary Supplement: Pea flour meal

Whole lentils

Experimental group

Description:

Whole cooked lentils in a 50 gram carbohydrate meal dose

Treatment:

Dietary Supplement: Whole lentils

Lentil flour

Experimental group

Description:

Lentil flour in a 50 gram carbohydrate meal dose

Treatment:

Dietary Supplement: Lentil flour