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

Metabolic Syndrome Clinical Trial

— PGRIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05145998
• Other study ID #: 17-191
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: February 29, 2020

Study information

• Verified date: November 2021
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Metabolic Syndrome
• Syndrome
• Type2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Glucola
50 grams of Glucola sugar beverage
• Whole pea meal
Whole cooked peas with spaghetti sauce and a slice of bread.
• Pea flour meal
Pea flour with spaghetti sauce and a slice of bread.
• Whole lentils
Whole cooked lentils with spaghetti sauce and a slice of bread.
• Lentil flour
Lentil flour with spaghetti sauce and a slice of bread.

Locations

Country	Name	City	State
United States	Iowa State University, Food Science and Human Nutrition Department	Ames	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Iowa State University	USA Dry Pea & Lentil Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in gastrointestinal symptoms	Gastrointestinal concerns and changes were noted on a descriptive questionnaire	3 hours postprandial, and 12 hours postprandial
Secondary	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