NCT05145998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2020

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
Last Updated

December 6, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

January 16, 2020

Last Update Submit

November 23, 2021

Conditions

Type2 Diabetes MellitusMetabolic Syndrome

Keywords

Glycemic responseGlucoseType 2 diabetesLegumesMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in gastrointestinal symptoms

    3 hours postprandial, and 12 hours postprandial

  • Change in satiety sensation

    Time 0 (fasting) then every 30 minutes for 3 hours

Study Arms (5)

Control - Glucola

ACTIVE COMPARATOR

Glucola control beverage

Dietary Supplement: Glucola

Whole peas

EXPERIMENTAL

Whole cooked peas in a 50 gram carbohydrate meal dose

Dietary Supplement: Whole pea meal

Pea Flour

EXPERIMENTAL

Pea flour in a 50 gram carbohydrate meal dose

Dietary Supplement: Pea flour meal

Whole lentils

EXPERIMENTAL

Whole cooked lentils in a 50 gram carbohydrate meal dose

Dietary Supplement: Whole lentils

Lentil flour

EXPERIMENTAL

Lentil flour in a 50 gram carbohydrate meal dose

Dietary Supplement: Lentil flour

Interventions

GlucolaDIETARY_SUPPLEMENT

50 grams of Glucola sugar beverage

Control - Glucola
Whole pea mealDIETARY_SUPPLEMENT

Whole cooked peas with spaghetti sauce and a slice of bread.

Whole peas
Pea flour mealDIETARY_SUPPLEMENT

Pea flour with spaghetti sauce and a slice of bread.

Pea Flour
Whole lentilsDIETARY_SUPPLEMENT

Whole cooked lentils with spaghetti sauce and a slice of bread.

Whole lentils
Lentil flourDIETARY_SUPPLEMENT

Lentil flour with spaghetti sauce and a slice of bread.

Lentil flour

Eligibility Criteria

Age24 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University, Food Science and Human Nutrition Department

Ames, Iowa, 50011, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus, Type 2

Interventions

Glucola

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System Diseases

Study Officials

  • Donna Winham, DrPH

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 5 x 5 crossover study with 4 treatments and one control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2020

First Posted

December 6, 2021

Study Start

May 23, 2018

Primary Completion

February 29, 2020

Study Completion

February 29, 2020

Last Updated

December 6, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)