Healthy VolunteersNCT06513052
Flavanol-rich Cocoa on Digestive and Cerebrovascular Health in the Colombian Adults
A study testing Commercial cocoa and High flavonols Cocoa in people with Healthy Volunteers, run by Vidarium, Nutrition, Health and Wellness Research Center at 1 site in Colombia.
Trial summary
The purpose of this study is to investigate the effects of consuming flavanol-rich cocoa on biomarkers associated with digestive and cerebrovascular health in a group of adults. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Commercial cocoa and High flavonols Cocoa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 5 Aug 2024to 26 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 20 and 50 years.
- Participants should be regular consumers of either table chocolate or cocoa powder
- Participants should have a BMI within the normal range, which is typically between 18.5 and 24.9 kg/m2. Overweight individuals with a BMI between 25 and 27 kg/m2 may also be eligible. (have a BMI within the normal or slightly overweight range)
Who cannot join
- Individuals who experience intolerance or adverse effects to the study products during the intervention period will be withdrawn from the trial
- Participants who become pregnant during the study will be excluded.
- Individuals who are diagnosed with Gastrointestinal diseases: This includes liver disorders, duodenal ulcers, gastritis, malabsorption disorders, short bowel syndrome, diverticulosis, Crohn's disease, ulcerative colitis, irritable bowel syndrome, and celiac disease. Central nervous system diseases: This includes vascular dementia and other neurodegenerative diseases. Inflammatory diseases, Malignant neoplasms, Diabetes mellitus, Cardiovascular diseases and Recent fractures.
- Significant alcohol consumption: Participants who consume more than 1 alcoholic drink per day for women or 2 alcoholic drinks per day for men.
- High coffee consumption: Participants who consume more than 2 cups of coffee per day will be excluded.
- Regular use of certain medications: Participants who regularly consume (within the past 3 months) any of the following medications: Metformin, Steroid anti-inflammatory drugs (NSAIDs) like dexamethasone, prednisone, triamcinolone, prednisolone, betamethasone, hydrocortisone, deflazacort, paramethasone, and fludrocortisone. Proton pump inhibitors (PPIs) like omeprazole, esomeprazole, lansoprazole, rabeprazole, pantoprazole, and dexlansoprazole. Hypnotic medications: These include drugs like zolpidem, zaleplon, alprazolam, diazepam, lorazepam, midazolam, and flurazepam. Antibiotics, antiparasitics, or laxatives. Medications containing acetylsalicylic acid (aspirin) or 5-alpha reductase inhibitors (finasteride, dutasteride).
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Vidarium, Nutrition, Health and Wellness Research Center
Medellín, Antioquia, 050023
About this study
Official title: Effect of Consuming Flavanol-rich Cocoa on Biomarkers Associated with Digestive and Cerebrovascular Health in the Colombian Adult Population
The purpose of this study is to investigate the effects of consuming flavanol-rich cocoa on biomarkers associated with digestive and cerebrovascular health in a group of adults.
Read the detailed description
The study seeks 40 adults aged 20-50 with normal or slightly overweight (by BMI) who regularly consume cocoa/chocolate. After recruitment, participants will receive a detailed explanation of the objectives and conditions of the study and will sign the informed consent and will be randomly assigned to randomly divided into two groups: Control Group that consumes a daily beverage with low-flavanol cocoa or the intervention group that consumes a daily beverage with high-flavanol cocoa. Participants in each intervention arm will be matched by BMI category (normal weight or overweight), sex (female or male), and age (plus or minus 5 years). Both groups will consume a single daily serving (8 grams) of their assigned cocoa (packaged individually) dissolved in low-fat and lactose-free milk (200 ml) before or with their breakfast. At baseline (time 0) and at the end of the intervention (12 weeks), each participant will be assessed for biological indicators gastrointestinal health, the composition of the gut microbiota and cerebrovascular health, markers associated with neuroinflammation, oxidative stress, and barrier function.
- Conditions
- Healthy Volunteers
- Being tested
- Commercial cocoa, High flavonols Cocoa
- Keywords
- Cocoa flavanols, Gut-brain axis, Gut microbiota, Vascular function, Gastrointestinal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercial cocoaOther
daily intake of a beverage made with 8 grams of commercial cocoa low in flavanols, dissolved in 200 mL of low-fat, lactose-free milk
High flavonols CocoaOther
Daily intake of a beverage made with 8 grams of cocoa high in flavanols, dissolved in 200 mL of low-fat, lactose-free milk.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | <100 mg cocoa flavanols/day for 12 weeks Receives: Other: Commercial cocoa |
| Intervention | Experimental | 500 mg cocoa flavanols/day for 12 weeks Receives: Other: High flavonols Cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal health
Changes in Gastrointestinal Symptom Assessment Scale (GSRS) scores. The GSRS is a 7-point scale ranging from 1 (no discomfort at all) to 7 (severe discomfort), with higher scores indicating worse gastrointestinal symptoms.
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Gut microbiota composition
Changes in the Abundance of the beneficial bacteria Bifidobacterium and Lactobacillus, as well as opportunistic pathogens belonging to the Enterobacteriaceae family.
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Vascular function
Changes in plasma levels of Endothelin-1 in pg/ml
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Secondary outcomes (11)
Blood pressure
Changes in systolic and diastolic blood pressure in mm Hg
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Blood lipid profile
Changes in serum levels of total cholesterol in mg/dL, LDL cholesterol in mg/dL, HDL cholesterol in mg/dL and triglycerides in mg/dL.
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Glucose metabolism
Changes in fasting blood glucose levels in mg/dL
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with neuroinflammation
Changes in plasma levels of interleukin 6 (IL-6) in pg/mL, and tumor necrosis factor alpha (TNF-α) in pg/mL
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with systemic inflammation
Changes in plasma levels of high sensitivity C reactive protein (hsCRP) in mg/L
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with oxidative stress
Changes in urine levels of 8-isoprostane corrected for creatinine clearance (ng/mg creatinine).
Corrected urine 8-isoprostane levels will be calculated by dividing urine 8-isoprostane levels in ng/ml by urine creatinine levels in mg/ml.
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Other markers associated with oxidative stress
Changes in plasma oxysterol levels in µg/ml
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with Barrier function
Plasma levels of Lipopolysaccharide-binding protein (LBP) in ng/ml, neuron-specific enolase (NSE) in ng/ml and neuregulin-1β in ng/ml.
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with angiogenesis
Changes in plasma levels of Vascular Endothelial Growth Factor (VEGF) in pg/ml
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with endothelial function
Changes in plasma levels of endocan in ng/ml, and endostatin in ng/ml
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Other markers associated with endothelial function
Changes in plasma levels of nitric oxide (NO) in micromol per liter (µM)
Measured: At baseline (time 0) and at the end of the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start5 Aug 2024
- Primary completion26 Dec 2024 (estimated)
- Study completion26 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vidarium, Nutrition, Health and Wellness Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- CES University, Compañia Nacional de Chocolates
- Responsible party
- Sponsor
- Investigators
- Jelver Sierra, PhD, Principal investigator, Vidarium, Nutrition, Health and Wellness Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513052
- Sponsor's protocol ID
- CF-2024
- Status last verified
- Oct 2024
- First submitted
- 12 Jul 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available when the results are published. The data can be obtained by downloading from the cloud (ex: Sequence Read Archive data at National center for biotechnology information (NCBI-SRA) or GitHub)
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consuming Flavanol-rich Cocoa on Biomarkers Associated with Digestive and Cerebrovascular Health in the Colombian Adult Population
- ClinicalTrials.gov ID
- NCT06513052
- Acronym / sponsor ID
- CF-2024
- Conditions
- Healthy Volunteers
- Keywords
- Cocoa flavanols, Gut-brain axis, Gut microbiota, Vascular function, Gastrointestinal health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vidarium, Nutrition, Health and Wellness Research CenterUniversity, hospital or other
- Collaborators
- CES University, Compañia Nacional de Chocolates
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 26 Dec 2024 (estimated)
- Study completion
- 26 Jan 2025 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of consuming flavanol-rich cocoa on biomarkers associated with digestive and cerebrovascular health in a group of adults.
Detailed description
The study seeks 40 adults aged 20-50 with normal or slightly overweight (by BMI) who regularly consume cocoa/chocolate. After recruitment, participants will receive a detailed explanation of the objectives and conditions of the study and will sign the informed consent and will be randomly assigned to randomly divided into two groups: Control Group that consumes a daily beverage with low-flavanol cocoa or the intervention group that consumes a daily beverage with high-flavanol cocoa. Participants in each intervention arm will be matched by BMI category (normal weight or overweight), sex (female or male), and age (plus or minus 5 years). Both groups will consume a single daily serving (8 grams) of their assigned cocoa (packaged individually) dissolved in low-fat and lactose-free milk (200 ml) before or with their breakfast. At baseline (time 0) and at the end of the intervention (12 weeks), each participant will be assessed for biological indicators gastrointestinal health, the composition of the gut microbiota and cerebrovascular health, markers associated with neuroinflammation, oxidative stress, and barrier function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Commercial cocoa<100 mg cocoa flavanols/day for 12 weeks |
| Intervention | Experimental | Other: High flavonols Cocoa500 mg cocoa flavanols/day for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women between 20 and 50 years.
- Participants should be regular consumers of either table chocolate or cocoa powder
- Participants should have a BMI within the normal range, which is typically between 18.5 and 24.9 kg/m2. Overweight individuals with a BMI between 25 and 27 kg/m2 may also be eligible. (have a BMI within the normal or slightly overweight range)
Key exclusion criteria (6 listed)
- Individuals who experience intolerance or adverse effects to the study products during the intervention period will be withdrawn from the trial
- Participants who become pregnant during the study will be excluded.
- Individuals who are diagnosed with Gastrointestinal diseases: This includes liver disorders, duodenal ulcers, gastritis, malabsorption disorders, short bowel syndrome, diverticulosis, Crohn's disease, ulcerative colitis, irritable bowel syndrome, and celiac disease. Central nervous system diseases: This includes vascular dementia and other neurodegenerative diseases. Inflammatory diseases, Malignant neoplasms, Diabetes mellitus, Cardiovascular diseases and Recent fractures.
- Significant alcohol consumption: Participants who consume more than 1 alcoholic drink per day for women or 2 alcoholic drinks per day for men.
- High coffee consumption: Participants who consume more than 2 cups of coffee per day will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial cocoadaily intake of a beverage made with 8 grams of commercial cocoa low in flavanols, dissolved in 200 mL of low-fat, lactose-free milk | Other | Control |
| High flavonols CocoaDaily intake of a beverage made with 8 grams of cocoa high in flavanols, dissolved in 200 mL of low-fat, lactose-free milk. | Other | Intervention |
Primary outcome
Gastrointestinal health
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in Gastrointestinal Symptom Assessment Scale (GSRS) scores. The GSRS is a 7-point scale ranging from 1 (no discomfort at all) to 7 (severe discomfort), with higher scores indicating worse gastrointestinal symptoms.
Gut microbiota composition
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in the Abundance of the beneficial bacteria Bifidobacterium and Lactobacillus, as well as opportunistic pathogens belonging to the Enterobacteriaceae family.
Vascular function
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Changes in plasma levels of Endothelin-1 in pg/ml
11 secondary outcomes
Blood pressure
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Blood lipid profile
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Glucose metabolism
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with neuroinflammation
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with systemic inflammation
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with oxidative stress
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Other markers associated with oxidative stress
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with Barrier function
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with angiogenesis
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Markers associated with endothelial function
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Other markers associated with endothelial function
Time frame: At baseline (time 0) and at the end of the intervention (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: Yes. The data will be available when the results are published. The data can be obtained by downloading from the cloud (ex: Sequence Read Archive data at National center for biotechnology information (NCBI-SRA) or GitHub)
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jelver Sierra, PhD principal investigator
Vidarium, Nutrition, Health and Wellness Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial cocoa and High flavonols Cocoa in people with Healthy Volunteers, run by Vidarium, Nutrition, Health and Wellness Research Center at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal health (time frame: At baseline (time 0) and at the end of the intervention (12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.