Glucose TolerancePhase 2NCT03714438
Effect of Medicago Sativa on Oral Glucose Tolerance in Healthy Adults
A Phase 2 study testing Medicago Sativa in people with Glucose Tolerance, run by University of Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Glucose Tolerance
- What is being tested?
- Medicago Sativa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- 7 Feb 2017to 30 Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults
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.
Read the detailed description
A randomized, double-blind, placebo-controlled, two-period, cross-over clinical trail will be carrie out in 15 healthy, sedentary individuals of both genders, who meet the following inclusion criteria: 25 to 40 years of age, normal fasting plasma glucose (≤ 5.5 mm/L), blood pressure (<130/90 mmHg), body mass index of 25 to 29.9 kg/m2, no taking any medication known to affect glucose tolerance, nondrinkers and nonsmokers. No pregnant, and lactation estate for female participants. They will be select from the same neighborhood and socioeconomic status.
After a fasting blood sample patients will be assigned at random-order through a closed-envelope selection, to receive one of two possible sequences during which they received either single oral doses of Medicago sativa or homologated placebo in 1,500 mg and were crossover with a difference of at least 7 days washout interval. Thirty minutes after each intervention patients underwent a 75-g oral glucose tolerant test (OGTT). Area under the curve of glucose and insulin, phases of insulin secretion, and insulin sensitivity will be calculate for each treatment period.
- Conditions
- Glucose Tolerance
- Being tested
- Medicago Sativa, Placebo
- Keywords
- Medicago sativa, Insulin secretion, Insulin Sensitivity
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicago SativaDrug
Also called Alfalfa, Lucerne
Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.
PlaceboDietary supplement
Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.
| Study group | Role | What they receive |
|---|---|---|
| Medicago sativa | Experimental | 1,500 mg unique dose, 30 min before the oral glucose tolerance test. Receives: Drug: Medicago Sativa |
| Placebo | Placebo comparator | 1,500 mg unique dose, 30 min before the oral glucose tolerance test. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose (FPG)
Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L.
Measured: 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
Measured: 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).
Measured: 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
Measured: 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)]
Measured: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Secondary outcomes (14)
Body Weight
Measured with minimal clothing and bare feet
Measured: At baseline of the study
Body Mass Index (BMI)
Calculated with the Quetelet index
Measured: At baseline of the study
Waist circumference (WC)
Measured with a flexible tape in them id point between the lowest rib and the iliac crest and is expressed in centimeters.
Measured: At baseline of the study
Systolic blood pressure (SBP)
Evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of systolic blood pressure expressed on mmHg
Measured: At baseline of the study
Diastolic Blood pressure (DBP)
Evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of diastolic blood pressure expressed on mmHg
Measured: At baseline of the study
Total Cholesterol (TC)
Determined after overnight fasting (10 to 12-h), determined by spectrophotometric methods. Expressed in mmol/L.
Measured: At baseline of the study
Triglycerides (TG)
Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.
Measured: At baseline of the study
High Density Lipoprotein Cholesterol (HDL- C)
Determined after overnight fasting (10 to 12-h), evaluated by colorimetric method, expressed on mmol/L.
Measured: At baseline of the study
Low Density Lipoprotein Cholesterol (LDL-C)
Determined after overnight fasting (10 to 12-h), calculated with the Friedewald equation LDL-C (mmol/L) = TC (mmol/L) - HDL-C (mmol/L) - [TG (mmol/L)/2.2] and very low-density lipoprotein (VLDL) for the proportion of TG (mmol/L)/2.2. Expressed in mmol/L.
Measured: At baseline of the study
Very Low Density Lipoprotein (VLDL)
Estimated by standardized techniques
Measured: At baseline of the study
Levels of aspartate aminotransferase in blood
Estimated by standardized techniques
Measured: At baseline of the study
Levels of alanine aminotransferase in blood
Estimated by standardized techniques
Measured: At baseline of the study
Levels of creatinine in blood
Estimated by standardized techniques
Measured: At baseline of the study
Levels of uric acid in blood
Estimated by standardized techniques
Measured: At baseline of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start7 Feb 2017
- Primary completion11 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lizet Yadira Rosales Rivera, University of Guadalajara
- Investigators
- Lizet Yadira Rosales-Rivera, PhD Science, Principal investigator, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714438
- Sponsor's protocol ID
- CT-MS-LYZ
- Status last verified
- Feb 2019
- First submitted
- 10 May 2018
- Last updated
- 21 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27389083Gawel 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.
PubMed 22744951Tai 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.
PubMed 8137688Stumvoll 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.
PubMed 10868854
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Administration of Medicago Sativa on Glucose Tolerance, Insulin Secretion and Insulin Sensitivity in Normoglycemic, Overweight Adults
- ClinicalTrials.gov ID
- NCT03714438
- Acronym / sponsor ID
- CT-MS-LYZ
- Conditions
- Glucose Tolerance
- Keywords
- Medicago sativa, Insulin secretion, Insulin Sensitivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, double-blind, placebo-controlled, two-period, cross-over clinical trail will be carrie out in 15 healthy, sedentary individuals of both genders, who meet the following inclusion criteria: 25 to 40 years of age, normal fasting plasma glucose (≤ 5.5 mm/L), blood pressure (<130/90 mmHg), body mass index of 25 to 29.9 kg/m2, no taking any medication known to affect glucose tolerance, nondrinkers and nonsmokers. No pregnant, and lactation estate for female participants. They will be select from the same neighborhood and socioeconomic status.
After a fasting blood sample patients will be assigned at random-order through a closed-envelope selection, to receive one of two possible sequences during which they received either single oral doses of Medicago sativa or homologated placebo in 1,500 mg and were crossover with a difference of at least 7 days washout interval. Thirty minutes after each intervention patients underwent a 75-g oral glucose tolerant test (OGTT). Area under the curve of glucose and insulin, phases of insulin secretion, and insulin sensitivity will be calculate for each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medicago sativa | Experimental | Drug: Medicago Sativa1,500 mg unique dose, 30 min before the oral glucose tolerance test. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo1,500 mg unique dose, 30 min before the oral glucose tolerance test. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medicago SativaAlso: Alfalfa, LucerneSingle oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test. | Drug | Medicago sativa |
| PlaceboSingle oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test. | Dietary supplement | Placebo |
Primary outcome
Fasting plasma glucose (FPG)
Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Glucose concentration after overnight fasting (10 to 12-h) determined by spectrophotometry methods. Expressed in mmol/L.
2 hour oral glucose tolerance test (2h-PG)
Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Glucose concentration after 75-g oral dextrose load, determined by spectrophotometry methods. Expressed in mmol/L
First Phase of Insulin Secretion
Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
calculated as 1283 + 1.829 x insulin 30' (mmol/L) - 138.7 x glucose 30' + 3.772 x insulin 0' (pmol/L).
Total Insulin Secretion
Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Insulinogenic index calculated as ΔAUC insulin /(ΔAUC glucose
Insulin sensitivity
Time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.
Matsuda index (insulin sensitivity) calculated as [10,000/square root of (glucose 0' X insulin 0')] (mean glucose X mean insulin during 2h-OGTT)]
14 secondary outcomes
Body Weight
Time frame: At baseline of the study
Body Mass Index (BMI)
Time frame: At baseline of the study
Waist circumference (WC)
Time frame: At baseline of the study
Systolic blood pressure (SBP)
Time frame: At baseline of the study
Diastolic Blood pressure (DBP)
Time frame: At baseline of the study
Total Cholesterol (TC)
Time frame: At baseline of the study
Triglycerides (TG)
Time frame: At baseline of the study
High Density Lipoprotein Cholesterol (HDL- C)
Time frame: At baseline of the study
Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: At baseline of the study
Very Low Density Lipoprotein (VLDL)
Time frame: At baseline of the study
Levels of aspartate aminotransferase in blood
Time frame: At baseline of the study
Levels of alanine aminotransferase in blood
Time frame: At baseline of the study
Levels of creatinine in blood
Time frame: At baseline of the study
Levels of uric acid in blood
Time frame: At baseline of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Background: PubMed 27389083Abdul-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.
- Background: PubMed 22744951Gawel 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.
- Background: PubMed 8137688Tai 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.
- Background: PubMed 10868854Stumvoll 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lizet Yadira Rosales-Rivera, PhD Science principal investigator
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medicago Sativa in people with Glucose Tolerance, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose (FPG) (time frame: After the acute administration of placebo and Medicago sativa. 15 days wash period between them.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714438, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.