A nutritional supplementation study with Colombian high flavanol cocoa

A nutritional supplementation study with Colombian high flavanol cocoa (CHFC): a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90234536

Enrollment

Registered

2017-07-25

Start date

2015-12-10

Completion date

Unknown

Last updated

2017-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular health Circulatory System

Interventions

A restricted randomization list was created using PASS 2008 (PASS, LLC. Kaysville, UT, USA) statistical software running on Windows Server 2008 R2 Standard SP1 64 bit Edition (Microsoft, USA) by a bio

~ 55 mg flavanols) 2. The second group took four pills/day (2 grams in total

~ 110 mg flavanols) 3. The last group took 8 pills/day (4 grams total ~ 220 mg flavanols) The participants were instructed to maintain their usual dietary intakes during the trial, and requested to r

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 25–50 years 2. Good general health 3. Body mass index between 22 and 30 kg/m2 4. No history of chronic diseases

Exclusion criteria

Exclusion criteria: 1. Individuals who were taking anti-inflammatory drugs, cardiovascular medications, lipid-altering drugs, and hormone replacement therapy 2. Smokers 3. Individuals engaged in vigorous exercise 4. Vegetarians 5. People who routinely take multivitamins or herbal supplements

Design outcomes

Primary

Measure	Time frame
Primary and secondary outcomes were measured at the same timepoints: before the beginning of the treatment (T-0) and after 2 hours (T-1), 2 weeks (T-2) and 4 weeks (T-3). 1. Urinary F2-Isoprostanes, determined by liquid chromatography–tandem mass spectrometry (LC-MS/MS) of morning urine sampled at the beginning of the study (baseline), at 2 weeks, and at the end of the study (4 weeks) 2. Plasma glutathione, determined with Glutathione HPLC kit (ImmundiagnostikAG, Bensheim, Germany) in whole blood samples 3. Blood fatty acid composition, analyzed by gas chromatography (Shimadzu) using a 30-m Omegawax 320 (Supelco-Sigma) capillary column 4. Plasma concentration of oxidized LDL, measured by a sandwich enzyme-linked immunosorbent assay method using a commercially available kit (Immundiagnostik AG, Bensheim, Germany)	—

Measure

Time frame

Primary and secondary outcomes were measured at the same timepoints: before the beginning of the treatment (T-0) and after 2 hours (T-1), 2 weeks (T-2) and 4 weeks (T-3). 1. Urinary F2-Isoprostanes, determined by liquid chromatography–tandem mass spectrometry (LC-MS/MS) of morning urine sampled at the beginning of the study (baseline), at 2 weeks, and at the end of the study (4 weeks) 2. Plasma glutathione, determined with Glutathione HPLC kit (ImmundiagnostikAG, Bensheim, Germany) in whole blood samples 3. Blood fatty acid composition, analyzed by gas chromatography (Shimadzu) using a 30-m Omegawax 320 (Supelco-Sigma) capillary column 4. Plasma concentration of oxidized LDL, measured by a sandwich enzyme-linked immunosorbent assay method using a commercially available kit (Immundiagnostik AG, Bensheim, Germany)

—

Secondary

Measure	Time frame
Triglycerides, total cholesterol (TC), high-density lipoprotein cholesterol (HDLc), and low-density lipoprotein cholesterol (LDLc), measured using colorimetric enzymatic tests (Thermo Scientific, Waltham, MA) before the beginning of the treatment (T-0) and after 2 hours (T-1), 2 weeks (T-2) and 4 weeks (T-3).	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026