SarcopeniaCOFRENCT03585868
Effects of COcoa Supplement in FRail Elderly Subjects (COFRE)
A study testing Flavonoids and No Flavonoids in people with Sarcopenia and Frail Elderly Syndrome, run by National Polytechnic Institute, Mexico.
Trial summary
The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo to evaluate the effect of daily consumption of a cocoa beverage on anthropometric, metabolic, oxidative stress, physical performance and quality of life. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Sarcopenia, Frail Elderly Syndrome
- What is being tested?
- Flavonoids and No Flavonoids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: both
- Age: 55-90 yo
- Waist circumference: Women > 80 cm, Men > 90 cm
- HDL-c: Women < 50 mg/dL, Men < 40 mg/dL
- Triglycerides: ≥ 150 mg/dL
- Glycemia: ≈100 mg/dL
Show all 13Show fewer
- Hand strength: Women< 20 kg, Men < 30 kg
- Up \& Go test: > 10 seconds
- Non-inclusion criteria:
- Any active infections
- Malignancies
- Habitual consumers of antioxidant supplements and cocoa products
- Use of benzodiazepines or protein supplements
Who cannot join
None listed.
About this study
Official title: Evaluation of the Effects of a COcoa Supplement to Reduce FRailty in the Elderly: COFRE a Randomized Clinical Trial
The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo to evaluate the effect of daily consumption of a cocoa beverage on anthropometric, metabolic, oxidative stress, physical performance and quality of life.
Read the detailed description
The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo randomly assigned to consumption of a flavonoid rich mixture (flavonoids; F), alkalinized cocoa which eliminates flavonoid content (no flavonoids; NF) or placebo. All beverages had similar physical characteristics and flavor. Cocoa beverages were provided in individual sachets containing a dry powder that was reconstituted with water just before consumption. Subjects were instructed as above to maintain their usual lifestyle, to limit intake of high caloric foods and flavonoid-containing foods and beverages, and to walk for 30 min/day.
To determine the effect of flavonoids, study evaluates anthropometric measures, metabolic parameters as glycemia and a lipid profile (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol). To evaluate oxidative stress damage as lipid oxidation is measured with the malondialdehyde (MDA) assay. Protein carbonylation is measured using an assay for detection of carbonyl groups that relies on 2,4-dinitrophenylhydrazine (DNPH) as a substrate. The investigators also evaluate interleukin-6 and tumor necrosis factor levels.
For physical performance is evaluated the handgrip strength, and mobility assesment with the following test: Six-minute walk test, two-minute step, sit-up test and the up \& go test.
The investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire.
- Conditions
- Sarcopenia, Frail Elderly Syndrome
- Being tested
- Placebo, Flavonoids, No Flavonoids
- Keywords
- flavonoids
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Beverage with no flavonoids
FlavonoidsOther
Flavonoids-enriched cacao beverage
No FlavonoidsDietary supplement
Beverage with alkalinized cocoa which eliminates flavonoid content
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Beverage without flavonoids Receives: Other: Placebo |
| No Flavonoids | Sham comparator | Beverage with alkalinized cocoa which eliminates flavonoid content Receives: Dietary Supplement: No Flavonoids |
| Flavonoids | Experimental | Beverage with a flavonoid rich mixture Receives: Other: Flavonoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Fasting blood level
Measured: At 90 days
Serum triacylglycerol concentration
Fasting blood level
Measured: At 90 days
Serum total cholesterol
Fasting blood level
Measured: At 90 days
Serum HDL cholesterol
Fasting blood level
Measured: At 90 days
Serum LDL cholesterol
Fasting blood level
Measured: At 90 days
Lipid oxidation
Serum malondialdehyde Levels
Measured: At 90 days
Protein oxidation
Serum protein carbonylation Levels
Measured: At 90days
Secondary outcomes (7)
Handgrip strength
Measures static force in kilograms that the hand can squeeze around a dynamometer
Measured: At 60 days
Up and go test
Measures time in seconds, a subject can rise and walk a 3-meter line and return to sit down
Measured: At 60 days
Six-minute walk test
Measures maximum distance in meters, a subject can walk at their normal gait and pace during 6 minutes
Measured: 6 minutes
Two-minute step in place test
Measures number of times a subject can rise each knee to the hip level during 2 minutes.
Measured: 2 minutes
Sit-up test
Measures number of times a subject can rise and sit-down in place during 30 seconds
Measured: 30 seconds
EQ-5D questionnaire
Self-administered health index that explores five domains
Measured: At 60 days
Analog Visual Scale
Use of a Analog Visual Scale to measure the quality of life, graded 0 (worst) to 100 (best) for the perception of wellbeing.
Measured: At 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2018
- Study startJan 2017
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Polytechnic Institute, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Ceballos Reyes, National Polytechnic Institute, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585868
- Sponsor's protocol ID
- COFRE-LIICM
- Acronym
- COFRE
- Status last verified
- Jul 2018
- First submitted
- 16 May 2018
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Munguia L, Rubio-Gayosso I, Ramirez-Sanchez I, Ortiz A, Hidalgo I, Gonzalez C, Meaney E, Villarreal F, Najera N, Ceballos G. High Flavonoid Cocoa Supplement Ameliorates Plasma Oxidative Stress and Inflammation Levels While Improving Mobility and Quality of Life in Older Subjects: A Double-Blind Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1620-1627. doi: 10.1093/gerona/glz107.
PubMed 31056655
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of a COcoa Supplement to Reduce FRailty in the Elderly: COFRE a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03585868
- Acronym / sponsor ID
- COFRE / COFRE-LIICM
- Conditions
- Sarcopenia, Frail Elderly Syndrome
- Keywords
- flavonoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Polytechnic Institute, MexicoUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Jul 2018 (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 study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo to evaluate the effect of daily consumption of a cocoa beverage on anthropometric, metabolic, oxidative stress, physical performance and quality of life.
Detailed description
The study use a double blind, placebo-controlled design enrolling male and female subjects between 55-90 yo randomly assigned to consumption of a flavonoid rich mixture (flavonoids; F), alkalinized cocoa which eliminates flavonoid content (no flavonoids; NF) or placebo. All beverages had similar physical characteristics and flavor. Cocoa beverages were provided in individual sachets containing a dry powder that was reconstituted with water just before consumption. Subjects were instructed as above to maintain their usual lifestyle, to limit intake of high caloric foods and flavonoid-containing foods and beverages, and to walk for 30 min/day.
To determine the effect of flavonoids, study evaluates anthropometric measures, metabolic parameters as glycemia and a lipid profile (triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol). To evaluate oxidative stress damage as lipid oxidation is measured with the malondialdehyde (MDA) assay. Protein carbonylation is measured using an assay for detection of carbonyl groups that relies on 2,4-dinitrophenylhydrazine (DNPH) as a substrate. The investigators also evaluate interleukin-6 and tumor necrosis factor levels.
For physical performance is evaluated the handgrip strength, and mobility assesment with the following test: Six-minute walk test, two-minute step, sit-up test and the up \& go test.
The investigators also assessed quality of life using the Health Related QoL (EQ-5D) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboBeverage without flavonoids |
| No Flavonoids | Sham comparator | Dietary Supplement: No FlavonoidsBeverage with alkalinized cocoa which eliminates flavonoid content |
| Flavonoids | Experimental | Other: FlavonoidsBeverage with a flavonoid rich mixture |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Sex: both
- Age: 55-90 yo
- Waist circumference: Women > 80 cm, Men > 90 cm
- HDL-c: Women < 50 mg/dL, Men < 40 mg/dL
- Triglycerides: ≥ 150 mg/dL
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PlaceboBeverage with no flavonoids | Other | Placebo |
| FlavonoidsFlavonoids-enriched cacao beverage | Other | Flavonoids |
| No FlavonoidsBeverage with alkalinized cocoa which eliminates flavonoid content | Dietary supplement | No Flavonoids |
Primary outcome
Blood glucose
Time frame: At 90 days
Fasting blood level
Serum triacylglycerol concentration
Time frame: At 90 days
Fasting blood level
Serum total cholesterol
Time frame: At 90 days
Fasting blood level
Serum HDL cholesterol
Time frame: At 90 days
Fasting blood level
Serum LDL cholesterol
Time frame: At 90 days
Fasting blood level
Lipid oxidation
Time frame: At 90 days
Serum malondialdehyde Levels
Protein oxidation
Time frame: At 90days
Serum protein carbonylation Levels
7 secondary outcomes
Handgrip strength
Time frame: At 60 days
Up and go test
Time frame: At 60 days
Six-minute walk test
Time frame: 6 minutes
Two-minute step in place test
Time frame: 2 minutes
Sit-up test
Time frame: 30 seconds
EQ-5D questionnaire
Time frame: At 60 days
Analog Visual Scale
Time frame: At 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Derived from this study: PubMed 31056655Munguia L, Rubio-Gayosso I, Ramirez-Sanchez I, Ortiz A, Hidalgo I, Gonzalez C, Meaney E, Villarreal F, Najera N, Ceballos G. High Flavonoid Cocoa Supplement Ameliorates Plasma Oxidative Stress and Inflammation Levels While Improving Mobility and Quality of Life in Older Subjects: A Double-Blind Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2019 Sep 15;74(10):1620-1627. doi: 10.1093/gerona/glz107.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flavonoids and No Flavonoids in people with Sarcopenia and Frail Elderly Syndrome, run by National Polytechnic Institute, Mexico.
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 13 inclusion and 0 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: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood glucose (time frame: At 90 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03585868, which also lists 1 linked publication.
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 13 Jul 2018.