Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03486145
Other study ID # AMPED1
Secondary ID
Status Completed
Phase N/A
First received June 8, 2017
Last updated March 27, 2018
Start date November 16, 2015
Est. completion date March 30, 2016

Study information

Verified date March 2018
Source Arizona State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It is hypothesized that the daily supplementation of a nitrate-rich, two-ounce fruit and vegetable energy supplement (Isagenix International LLC) by healthy young adults with a would increase circulating nitrates and improve cardiovascular parameters compared to a nitrate-deficient placebo (prune juice).


Description:

Endothelial cells of the peripheral vasculature are key sources of vasoactive factors regulating healthy blood pressure. One of the primary vasodilatory factors released from these cells is nitric oxide (NO). Production of NO is stimulated both through enzymatic-dependent mechanisms via NO synthase, as well as from dietary intake of nitrate-containing foods or supplements that increase NO bioavailability. This study examined whether the daily consumption of a nitrate-rich, two-ounce fruit and vegetable energy supplement (Isagenix International LLC) would increase circulating nitrates and improve cardiovascular parameters compared to a nitrate-deficient placebo (prune juice). Healthy male adults aged 18-40y (n=45) were recruited to participate in this longitudinal double-blind, placebo-controlled, randomized clinical trial. Subjects maintained their typical diet and physical activity patterns during the study. Anthropometric and cardiovascular (blood pressure and flow-mediated dilation (FMD)) parameters, along with plasma nitrates and nitrites were measured at baseline and after one and two weeks of supplementation. Subjects also completed questionnaires on sleep quality and mood. It is hypothesized that the nitrate-rich FVS supplement will provide a good source of dietary nitrates and effectively reduced blood pressure in normotensive, healthy young males.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date March 30, 2016
Est. primary completion date March 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

• healthy men aged 18-40y

Exclusion Criteria:

- hypo- or hypertension (blood pressure < 100/65 or >140/90

- cigarette use within past year

- food allergies

- specific medication use (nitroglycerin, beta-blockers, calcium channel blockers),

- unwillingness to drink juice concentrates and follow study restrictions.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
fruit and vegetable juice supplement
FVS was provided by Isagenix International LLC in identically sealed bottles labeled labeled "B". Subjects were not told which supplement they received. Each bottle contained one serving (two ounces) of the supplement.
Placebo
PRU was provided by Isagenix International LLC in identically sealed bottles labeled labeled "A". Subjects were not told which supplement they received. Each bottle contained one serving (two ounces) of the supplement.

Locations

Country Name City State
United States Arizona State University Phoenix Arizona

Sponsors (3)

Lead Sponsor Collaborator
Arizona State University Brendan Miller, Karen L. Sweazea

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other FMD and mood The association of FMD with mood Two week change in FMD and mood
Other FMD and sleep quality The association of FMD with sleep quality Two week change in FMD and sleep quality
Primary Plasma nitrates and nitrites The primary objective of this study was to examine the short-term effects of a novel, two-ounce nitrate-rich fruit and vegetable supplement (FVS) (AMPED NOx, Isagenix International LLC) on plasma nitrates and nitrites in healthy young men. Two week change in concentration (week 2 - baseline)
Primary Flow-mediated dilation The primary objective of this study was to examine the short-term effects of a novel, two-ounce nitrate-rich fruit and vegetable supplement (FVS) (AMPED NOx, Isagenix International LLC) on endothelial function in healthy young men. Two week change in dilation (week 2 - baseline)
Primary Blood pressure The primary objective of this study was to examine the short-term effects of a novel, two-ounce nitrate-rich fruit and vegetable supplement (FVS) (AMPED NOx, Isagenix International LLC) on blood pressure in healthy young men. Two week change in blood pressure (week 2 - baseline)
Secondary Effect of athletic status on endothelial function To explore whether athletic status modified the flow mediated dilation response to the supplement athletes Two week change in flow mediated dilation (week 2 - baseline) by athletic status
Secondary Effect of athletic status on blood pressure To explore whether athletic status modified the blood pressure response to supplementation Two week change in blood pressure (week 2 - baseline) by athletic status
See also
  Status Clinical Trial Phase
Completed NCT03812614 - Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support N/A
Completed NCT03650166 - High BP and Home Monitoring Experience (HoME) Study N/A
Recruiting NCT02908139 - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients N/A
Completed NCT01622400 - Efficacy of a Dedicated Therapeutic Education Program in Patients at High Cardiovascular Risk N/A
Completed NCT00659672 - Effect of Whey Protein on Blood Pressure N/A
Completed NCT00473681 - Intervention Study to Control High Blood Pressure for Korean American N/A
Completed NCT03542240 - Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome N/A
Active, not recruiting NCT05526092 - OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals N/A
Completed NCT02218931 - ESTEEM - Effect of Simple, Targeted Diet in Pregnant Women With Metabolic Risk Factors on Pregnancy Outcomes N/A
Recruiting NCT03753204 - Salt-Sensitivity and Immunity Cell Activation Phase 1/Phase 2
Not yet recruiting NCT04064281 - The Healthy Cantonese Diet on Cardiometabolic Syndrome N/A
Completed NCT04479384 - The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study. N/A
Completed NCT04082819 - MediBeat - HeartBeat Observation Trial N/A
Completed NCT03555344 - Effect of Mantra on Hypertensive Patients N/A
Withdrawn NCT03319823 - Treating Nocturnal Hypertension and Nocturia in African American Men Phase 4
Completed NCT00689819 - Pre-clinical Cardiac Dysfunction Among Asymptomatic Hypertensive Patients N/A
Completed NCT00417170 - Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome Phase 2
Completed NCT00130156 - Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension Phase 4
Completed NCT05808556 - Sticker Pad Containing Essential Oil in Volunteer With High Blood Pressure N/A
Recruiting NCT05321368 - A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities N/A