Intra-individual Real Life Effects of Cocoa Flavanols on Blood Pressure and Arterial Stiffness

NCT05446818 | Completed

• 1 other identifier: FER-1819-040
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Very controlled dietary intervention studies support that individual polyphenol rich foods and isolated polyphenols can increase endothelial function and HDL cholesterol and decrease blood pressure, arterial stiffness, and LDL cholesterol even in healthy subjects. The intake of (-)-epicatechin, the major polyphenol in cocoa, was previously mechanistically linked with acute improvements in endothelial function and nitric oxide availability. A profound understanding of inter- and intra-individual variability of responses in real life are an important area of research in a world that aims at personalized nutrition and medicine. N-of-1 trials are a powerful tool allowing to study small effects even in fewer subjects and help account for intra-individual variations in responses. The overall aim of the present pilot study is to evaluate intra-and inter-individual variability of responses to cocoa flavanols in everyday life using the N-of-1 paradigm. In this pilot study, young healthy humans will monitor blood pressure, pulse wave velocity, heart rate, diet, and physical activity on 8 days using a personal and wearable devices. Each subject will undergo the 8 study days; 4 days with cocoa flavanol capsules (CF; containing 750 mg (1500 mg per day)) and 4 days with calorically matched placebo capsules (P; 0 mg cocoa flavanols) taken at the same time in the morning with breakfast and at night before going to bed. The subjects will be randomized to different treatment allocation sequences to allow blinding of volunteers and investigator; either CF-P-CF-P-CF-P-CF-P or P-CF-P-CF-P-CF-P-CF.

Conditions

Blood Pressure; Stiffness, Vascular; Sleep

Outcome Measures

Primary Outcomes (3)

• Change in systolic and diastolic blood pressure

  Standard upper arm cuff (day) and wrist band (day and night)

  Measurements over 24 hours

• Change in arterial stiffness

  Pulse wave velocity by finger clip (iHeart)

  Measurements over 24 hours

• Change in heart rate

  Fitness bracelet

  Measurements over 24 hours

Secondary Outcomes (1)

• Physical activity

  Assessed over 24 hours

Other Outcomes (1)

• Dietary composition

  Assessed over 24 hours

Study Arms (2)

Flavanol first

ACTIVE COMPARATOR

Subjects will receive over 8 days both cocoa flavanols (CF) and placebo (P) capsules on alternating days. Sequence of this arm is: CF-P-CF-P-CF-P-CF-P

Dietary Supplement: Cocoa flavanol (CF); Other: Placebo (P)

Placebo first

ACTIVE COMPARATOR

Subjects will receive over 8 days both cocoa flavanols (CF) and placebo (P) capsules on alternating days. Sequence of this arm is: P-CF-P-CF-P-CF-P-CF

Dietary Supplement: Cocoa flavanol (CF); Other: Placebo (P)

Interventions

Cocoa flavanol (CF) DIETARY_SUPPLEMENT

2 times per day 750 mg cocoa flavanols (each delivered in 6 CocoaVia capsules)

Flavanol first; Placebo first

Placebo (P) OTHER

2 times per day 0 mg cocoa flavanols calorically matched control (delivered in 6 identical capsules)

Flavanol first; Placebo first

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Body mass index \<30 kg/m2
• Age \<45 years

You may not qualify if:

• Diabetes mellitus
• Symptoms of acute infection
• Cardiac arrhythmia
• Active malignancy
• Clinical signs or symptoms of cardiovascular disease including:
• Angina pectoris
• Shortness of breath
• Palpitations
• Syncopes
• Claudication
• Active vasoactive medication
• Vitamin supplements.

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

University of Surrey

Guildford, GU2 7XH, United Kingdom

Location

Study Officials

• Christian Heiss, MD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Intervention and placebo in same number and size of capsules
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Series of Repeated Cross-over Randomized Controlled Double-blind N-of-1 Pilot Studies; each subject receives 4 times treatment and 4 times placebo

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: July 7, 2022
• Study Start: April 22, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 7, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)