NCT03492983

Brief Summary

This is a randomized clinical trial aimed at postmenopausal women aged 50 to 64 years old selected in urban primary care centers of two centers (Spain). Its objective is to evaluate the effects of the additional intake of high cocoa content chocolate on blood pressure, vascular function, body composition, quality of life and cognitive performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1.2 years

First QC Date

March 23, 2018

Last Update Submit

February 20, 2020

Conditions

Postmenopausal Women

Keywords

CocoaVascular functionBody compositionQuality of lifeCognitive performancePostmenopausal women

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Measurement by oscillometric method (mmHg)

    6 months

Secondary Outcomes (5)

  • Arterial stiffness

    6 months

  • Wave reflection

    6 months

  • Body composition

    6 months

  • Quality of life

    6 months

  • Cognitive performance

    6 months

Study Arms (2)

Control group

NO INTERVENTION

No intervention

Intervention group

EXPERIMENTAL

Addition of 10 g/day of high cocoa content chocolate to the usual diet for six months

Dietary Supplement: Intervention group

Interventions

Intervention groupDIETARY_SUPPLEMENT

10 g/day of high cocoa content chocolate for six months.

Intervention group

Eligibility Criteria

Age50 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women in postmenopausal period defined as 12 consecutive months of amenorrhea.

You may not qualify if:

  • Older than 65 years.
  • Cardiovascular disease (acute myocardial infarction, stroke).
  • Arterial hypertension on treatment.
  • Diabetes mellitus.
  • Dyslipidemia (total cholesterol \>250 mg/dL or in lipid-lowering therapy).
  • Clinically demonstrable neurological and/or neuropsychological disorders.
  • Hormone replacement therapy.
  • Allergy and/or intolerance to cocoa or any of the components of the supplement.
  • Hypocaloric diet.
  • Any other circumstance that the investigators consider could interfere with the study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Biosanitario de Salamanca. Research unit La Alamedilla

Salamanca, 37003, Spain

Location

Related Publications (2)

  • Garcia-Yu IA, Garcia-Ortiz L, Gomez-Marcos MA, Rodriguez-Sanchez E, Mora-Simon S, Maderuelo-Fernandez JA, Recio-Rodriguez JI. Effects of cocoa-rich chocolate on cognitive performance in postmenopausal women. A randomised clinical trial. Nutr Neurosci. 2022 Jun;25(6):1147-1158. doi: 10.1080/1028415X.2020.1840119. Epub 2020 Nov 15.

    PMID: 33190575DERIVED

  • Garcia-Yu IA, Garcia-Ortiz L, Gomez-Marcos MA, Alonso-Dominguez R, Gonzalez-Sanchez J, Mora-Simon S, Gonzalez-Manzano S, Rodriguez-Sanchez E, Maderuelo-Fernandez JA, Recio-Rodriguez JI. Vascular and cognitive effects of cocoa-rich chocolate in postmenopausal women: a study protocol for a randomised clinical trial. BMJ Open. 2018 Dec 14;8(12):e024095. doi: 10.1136/bmjopen-2018-024095.

    PMID: 30552275DERIVED

Study Officials

  • Jose I Recio-Rodriguez, PhD

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

April 10, 2018

Study Start

June 1, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)