Clinical trial NCT05145998: Metabolic Effects of Pulse Consumption on Biomarkers in Adults With Type 2 Diabetes or Met Syn
Official title: Metabolic Effects of Pulse Consumption on Biomarkers in Adults With Type 2 Diabetes Mellitus or Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes Mellitus
Metabolic Syndrome
Keywords: Glycemic response
Glucose
Type 2 diabetes
Legumes
Metabolic Syndrome
Lead sponsor: Iowa State University
Sponsor class: OTHER
Collaborators: name: USA Dry Pea & Lentil Council
First posted: 2021-12-06
Enrollment: 19
Sex: ALL
Minimum age (years): 24
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 5 x 5 crossover study with 4 treatments and one control
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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.

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 gastrointestinal symptoms
timeFrame: 3 hours postprandial, and 12 hours postprandial
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:
affiliation: Iowa State University
name: Donna Winham, DrPH
role: PRINCIPAL_INVESTIGATOR
References: