Assessment of Delphinol® Dose on Vascular Function

NCT07196059 | Completed

• 1 other identifier: PRO-FY2020-66
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Maqui berry standardized extract (e.g. Delphinol®) has been used with success to modulate blood glucose and associated variables at a dosage of 450mg daily. Lower dosages have also been used with favorable effects. However, it is unknown what dosage is optimal for positively impacting vascular function. The purpose of this study is to determine the impact of Maqui berry standardized extract (e.g. Delphinol®) at varying dosages on vascular function assessed using the perfusion index, Vendys, and blood nitrate/nitrite concentrations.

Conditions

Healthy

Keywords

Delphinol; antioxidant; vascular function

Outcome Measures

Primary Outcomes (15)

• Baseline Perfusion Index

  Perfusion index will be measured using a fingertip pulse oximeter prior to first arm of study.

  On day 1

• Perfusion Index after 60 mg Delphinol treatment

  Perfusion index will be measured using a fingertip pulse oximeter on the 8th day of 60 mg Delphinol treatment.

  90 min post supplement ingestion on day 8 of treatment

• Perfusion Index after 120 mg Delphinol treatment

  Perfusion index will be measured using a fingertip pulse oximeter on the 8th day of 120 mg Delphinol treatment.

  90 min post supplement ingestion on day 8 of treatment

• Perfusion Index after 180 mg Delphinol treatment

  Perfusion index will be measured using a fingertip pulse oximeter on the 8th day of 180 mg Delphinol treatment.

  90 min post supplement ingestion on day 8 of treatment

• Perfusion Index after placebo treatment

  Perfusion index will be measured using a fingertip pulse oximeter on the 8th day of placebo treatment.

  90 min post supplement ingestion on day 8 of treatment

• baseline Vendys II endothelial measure

  Endothelial measure will be determined using Vendys II (a tool to measure endothelial vascular function via digital thermal monitoring) prior to first arm of study

  On day 1

• Vendys II endothelial measure after 60 mg Delphinol treatment

  Endothelial measure will be determined using Vendys II (a tool to measure endothelial vascular function via digital thermal monitoring) 90 min post 60 mg Delphinol treatment ingestion

  90 min post treatment ingestion on day 8 of treatment

• Vendys II endothelial measure after 120 mg Delphinol treatment

  Endothelial measure will be determined using Vendys II (a tool to measure endothelial vascular function via digital thermal monitoring) 90 min post 120 mg Delphinol treatment ingestion

  90 min post treatment ingestion on day 8 of treatment

• Vendys II endothelial measure after 180 mg Delphinol treatment

  Endothelial measure will be determined using Vendys II (a tool to measure endothelial vascular function via digital thermal monitoring) 90 min post 180 mg Delphinol treatment ingestion

  90 min post treatment ingestion on day 8 of treatment

• Vendys II endothelial measure after placebo treatment

  Endothelial measure will be determined using Vendys II (a tool to measure endothelial vascular function via digital thermal monitoring) 90 min post placebo treatment ingestion

  90 min post supplement ingestion on day 8 of treatment

• Baseline Blood nitrate/nitrite

  Baseline blood nitrate/nitrite will be determined prior to first arm of study

  On day 1

• Blood nitrate/nitrite after 60 mg Delphinol treatment

  Blood nitrate/nitrite will be determined on 8th day of treatment, 90 min post 60 mg Delphinol treatment ingestion

  90 min post treatment ingestion on day 8 of treatment

• Blood nitrate/nitrite after 120 mg Delphinol treatment

  Blood nitrate/nitrite will be determined on 8th day of treatment, 90 min post 120 mg Delphinol treatment ingestion

  90 min post treatment ingestion on day 8 of treatment

• Blood nitrate/nitrite after 180 mg Delphinol treatment

  Blood nitrate/nitrite will be determined on 8th day of treatment, 90 min post 180 mg Delphinol treatment ingestion

  90 min post treatment ingestion on day 8 of treatment

• Blood nitrate/nitrite after placebo treatment

  Blood nitrate/nitrite will be determined on 8th day of treatment, 90 min post placebo treatment ingestion

  90 min post treatment ingestion on day 8 of treatment

Secondary Outcomes (2)

• Blood pressure

  At baseline and on day 8 of each treatment, prior to treatment ingestion

• Heart rate

  At baseline and on day 8 of each treatment, prior to treatment ingestion

Study Arms (4)

60mg Delphinol®

EXPERIMENTAL

Capsule to be taken daily for 8 days

Dietary Supplement: Delphinol

120 mg Delphinol

EXPERIMENTAL

Capsule to be taken daily for 8 days

Dietary Supplement: Delphinol

180 mg Delphinol

EXPERIMENTAL

Capsule to be taken daily for 8 days

Dietary Supplement: Delphinol

Placebo

PLACEBO COMPARATOR

Capsule to be taken daily for 8 days

Dietary Supplement: Placebo

Interventions

Delphinol DIETARY_SUPPLEMENT

Contains maqui berry powder

120 mg Delphinol; 180 mg Delphinol; 60mg Delphinol®

Placebo DIETARY_SUPPLEMENT

Contains cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

* age 18-35 years * male or female * body mass index (BMI) between 18-29.9 kg/m2 (not obese) * non-smoker * no diagnosed history of diabetes * no diagnosed history of cardiovascular disease including any vascular disease * no diagnosed history of neurological disease * no consumption of alcohol or fruit within 48 hours of testing * no consumption of caffeine-containing beverages within at least 48 hours of testing * 12-lead ECG without significant heart rate and rhythm abnormalities and blood glucose within normal limits (as reviewed by Tara Hunter, BSN and confirmed by Dr. John Hyden, MD as needed) * if female, not be pregnant

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Memphis: lead
• Anklam-Extrakt GmbH: collaborator

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Interventions

Delphinol

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of School of Health Studies

Model Details: Participants will receive each of 4 interventions over approximately 8 weeks. On the first day baseline measures will be obtained, and participants will begin the first treatment. For each arm, participants will take the treatment daily for 8 days. They will then return to the lab on the 8th day. Participants will then have a "wash out" period of 7 days prior to the start of the next arm.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: March 5, 2020
• Primary Completion: March 24, 2020
• Study Completion: March 25, 2020
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

US (1)