The Effect of 4 Weeks of L-Citrulline Supplementation on Macro- and Microvascular Function in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to examine the effect of 4 weeks of Citrulline supplementation on macro- and microvascular function during acute hyperglycemia in middle-aged and older adults with type 2 diabetes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of L-citrulline Supplementation on Vascular Function in Metabolic Syndrome

NCT06025357

Metabolic Syndrome Menopause

COMPLETED NA

Effect of L-Citrulline Supplementation on Arginase Activity and Vascular Function in Diabetes

NCT03358264

Type 2 Diabetes Mellitus

UNKNOWN NA

Vitamin C and Cardiovascular Risk

NCT00534014

Atherosclerosis Type 2 Diabetes

COMPLETED NA

Effects of a Dietary Supplement Containing L-Arabinose and Trivalent Patented Food-source of Chromium on Blood Glucose and Insulin

NCT01107431

Pre-diabetes

COMPLETED NA

The Effects of Micronutrients in Combination With Usual Care in Type 2 Diabetes

NCT01738802

Type 2 Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Using a double-blind, randomized, placebo-controlled, and cross-over design, middle-aged and older adults with type 2 diabetes will be randomized to receive either CIT supplementation (6g/day) or placebo (Microcrystalline Cellulose, 6g/day) for 4 weeks.

There will be a total of 5 laboratory visits. Visit 1 (screening visit) will take approximately 1 hour and 30 minutes, visit 2 will take approximately 2 hours and 30 minutes, and visits 3-5 will be approximately 3 hours each.

Visit 1 will measure blood pressure, blood glucose and lipid levels, anthropometry, body composition, and muscle strengths. Visits 2-5 will assess vascular function and glucose control during fasted and acute hyperglycemia conditions induced by 75g of glucose ingestion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind (subject, investigator), randomized, cross-over, placebo-controlled

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Double-blind (subject, investigator), randomized, cross-over, placebo-controlled

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

L-citrulline

6 grams/day

Group Type EXPERIMENTAL

L-citrulline

Intervention Type DIETARY_SUPPLEMENT

4 weeks of L-citrulline (6 g/day) in 8 capsules. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Placebo

Microcrystalline cellulose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

4 weeks of microcrystalline cellulose in 8 capsules. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

L-citrulline

4 weeks of L-citrulline (6 g/day) in 8 capsules. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Intervention Type DIETARY_SUPPLEMENT

Placebo

4 weeks of microcrystalline cellulose in 8 capsules. Supplementation will be ingested daily, half of the doses in the morning and half at night.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Middle-aged and older women and men between 40-75 years old
* A physician diagnosed type 2 diabetes at least 3 months ago
* Treated with an oral hypoglycemic medication
* Body mass index \< 40 kg/m2
* Systolic blood pressure \< 160 mmHg
* Sedentary (defined as \< 120 min/week of exercise)
* Not currently participating in exercise or dietary interventions for at least 2 months prior the present study and willing to abstain from participating in those strategies during the duration of this study.

Exclusion Criteria

* \< 40 years of age and \> 65 years of age
* Use of medications and/or any supplements that may affect outcome variables (such as arginine- or citrulline-containing supplements, nitrates, and nitroglycerin)
* Body mass index ≥ 40 kg/m2
* Systolic blood pressure ≥ 160 mmHg
* Recent changes in medications within 3 months
* Current smoking any tobacco use
* Type 1 diabetes, severe cardiovascular/renal/pulmonary diseases
* More than 7 alcoholic drinks/week of consumption
* Premenopausal women with an irregular menstrual cycle (oligomenorrhea) or pregnancy

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes