Cocoa Intake and Muscle Pain Sensation

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT05378984

Collaborator

(none)

Enrollment

Location

Arms

9.7

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This experimental randomized, double-blind, and controlled study included fifteen young, healthy, and pain-free men and 15 age-matched women.

It lasted for three visits with at least one-week washout. Pain was experimentally induced, twice at each visit, with intramuscular injections of 0.2 mL hypertonic saline (5%), before and after intake of one of the different chocolate-types; white (30% cocoa-content), milk (34% cocoa-content), dark (70% cocoa-content). Pain duration, pain area, peak pain, and pressure pain threshold were assessed every fifth minute after each injection, between the time-points 5 to 30 min.

Prior to inclusion, all participants underwent an examination in a dental chair. This included a clinical examination of the orofacial region according to the Diagnostic Criteria for temporomandibular disorders (DC/TMD) by a blinded examiner. Participants were also examined regarding their psychosocial status prior to inclusion, this included depression, somatization, anxiety, pain catastrophizing and stress.

Condition or Disease	Intervention/Treatment	Phase
Muscle Pain	Other: before - hypertonic saline 5% Other: after - hypertonic saline 5%	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The chocolate given to the participant was of a different concentration of cocoa, distributed in a randomized and double-blinded order. The participants where given the chocolate with their eyes closed. A non-blinded examiner fed the chocolate to the participant at each clinical trial, while a blinded examiner did the assessments. The different types of chocolates were given at three different visits to all participants with at least one week of washout in between. To randomize the order in which the chocolates were given to each participant, an internet-based site was used (www.randomization.com; Seed 19525). The randomization was done in five blocks of six participants each, by a researcher who did not participate in the data collection

Primary Purpose:

Other

Official Title:

Cocoa Intake and Muscle Pain Sensation: an Experimental Study

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Dec 20, 2020

Actual Study Completion Date :

Dec 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dark Chocolate	Other: before - hypertonic saline 5% pain was induced by intramuscular injections of hypertonic saline (5%) Other: after - hypertonic saline 5% pain was induced by intramuscular injections of hypertonic saline (5%)
Active Comparator: Milk Chocolate	Other: before - hypertonic saline 5% pain was induced by intramuscular injections of hypertonic saline (5%) Other: after - hypertonic saline 5% pain was induced by intramuscular injections of hypertonic saline (5%)
Active Comparator: White Chocolate	Other: before - hypertonic saline 5% pain was induced by intramuscular injections of hypertonic saline (5%) Other: after - hypertonic saline 5% pain was induced by intramuscular injections of hypertonic saline (5%)

Arm

Intervention/Treatment

Active Comparator: Dark Chocolate

Other: before - hypertonic saline 5%