NCT03714438

Brief Summary

Previous preclinical investigations have found that Medicago sativa promotes the decrease of glucose concentrations. To evaluate the acute effect of Medicago sativa administration on glucose tolerance, insulin secretion, and insulin sensitivity in healthy individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_2

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

February 7, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

May 10, 2018

Last Update Submit

February 19, 2019

Conditions

Glucose Tolerance

Keywords

Medicago sativaInsulin secretionInsulin Sensitivity

Outcome Measures

Primary Outcomes (5)

  • Fasting plasma glucose (FPG)

    Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L.

    After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

  • 2 hour oral glucose tolerance test (2h-PG)

    Glucose concentration after 75-g oral dextrose load, determined by spectrophotometry methods. Expressed in mmol/L

    After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

  • First Phase of Insulin Secretion

    calculated as 1283 + 1.829 x insulin 30' (mmol/L) - 138.7 x glucose 30' + 3.772 x insulin 0' (pmol/L).

    After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

  • Total Insulin Secretion

    Insulinogenic index calculated as ΔAUC insulin /(ΔAUC glucose

    After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

  • Insulin sensitivity

    Matsuda index (insulin sensitivity) calculated as \[10,000/square root of (glucose 0' X insulin 0')\] (mean glucose X mean insulin during 2h-OGTT)\]

    After the acute administration of placebo and Medicago sativa. 15 days wash period between them.

Secondary Outcomes (14)

  • Body Weight

    At baseline of the study

  • Body Mass Index (BMI)

    At baseline of the study

  • Waist circumference (WC)

    At baseline of the study

  • Systolic blood pressure (SBP)

    At baseline of the study

  • Diastolic Blood pressure (DBP)

    At baseline of the study

  • +9 more secondary outcomes

Study Arms (2)

Medicago sativa

EXPERIMENTAL

1,500 mg unique dose, 30 min before the oral glucose tolerance test.

Drug: Medicago Sativa

Placebo

PLACEBO COMPARATOR

1,500 mg unique dose, 30 min before the oral glucose tolerance test.

Dietary Supplement: Placebo

Interventions

Medicago SativaDRUG

Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.

Also known as: Alfalfa, Lucerne
Medicago sativa
PlaceboDIETARY_SUPPLEMENT

Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.

Placebo

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fasting plasma glucose ≤99 mg/dL.
  • Two hours postload plasma glucose (100 a 139 mg/dL).
  • Body mass Index: 25 -39.9 kg/m2.
  • body weight stable over the last 3 months.
  • Women in follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of laboratory tests.
  • Sedentary.
  • Nonsmokers.
  • Body weight unchanged upper to 5% for at least 3 moths before the study.

You may not qualify if:

  • Women in pregnancy and/or breastfeeding
  • Physical or mental disability that makes it impossible to perform the intervention.
  • Diagnosis of hypertension or heart failure.
  • Untreated thyroid disease.
  • Consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose and lipids (oral hypoglycemic agents, insulin, lipid-lowering).
  • Diagnosis of liver disease or elevation twice of the upper normal value of liver enzymes.
  • Diagnosis of renal disease or creatinine \>1.5 mg/dL.
  • Diagnosis of prediabetes: Fasting plasma glucose ≥100 mg/dL and/or 2h-OGTT ≥140mg/dL and/or glycated hemoglobin A1c (A1C) between 5.7 - 6-4 %.
  • Diagnosis of Type 2 Diabetes Mellitus (T2DM): Fasting glucose ≥ 126 mg / dL and/or 2h-OGTT ≥ 200 mg/dL .
  • Total Cholesterol ≥ 280 mg/dL.
  • Triglycerides ≥ 300 mg/dL.
  • Known allergy to calcined magnesia or Medicago sativa.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Guadalajara, Jalisco, 44340, Mexico

Location

Related Publications (4)

  • Abdul-Ghani M, DeFronzo RA, Jayyousi A. Prediabetes and risk of diabetes and associated complications: impaired fasting glucose versus impaired glucose tolerance: does it matter? Curr Opin Clin Nutr Metab Care. 2016 Sep;19(5):394-399. doi: 10.1097/MCO.0000000000000307.

    PMID: 27389083BACKGROUND

  • Gawel E. Chemical composition of lucerne leaf extract (EFL) and its applications as a phytobiotic in human nutrition. Acta Sci Pol Technol Aliment. 2012 Jul-Sep;11(3):303-10.

    PMID: 22744951BACKGROUND

  • Tai MM. A mathematical model for the determination of total area under glucose tolerance and other metabolic curves. Diabetes Care. 1994 Feb;17(2):152-4. doi: 10.2337/diacare.17.2.152.

    PMID: 8137688BACKGROUND

  • Stumvoll M, Mitrakou A, Pimenta W, Jenssen T, Yki-Jarvinen H, Van Haeften T, Renn W, Gerich J. Use of the oral glucose tolerance test to assess insulin release and insulin sensitivity. Diabetes Care. 2000 Mar;23(3):295-301. doi: 10.2337/diacare.23.3.295.

    PMID: 10868854BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Lizet Yadira Rosales-Rivera, PhD Science

    Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher Professor

Study Record Dates

First Submitted

May 10, 2018

First Posted

October 22, 2018

Study Start

February 7, 2017

Primary Completion

January 11, 2018

Study Completion

January 30, 2018

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations

ME(1)