Insulin SensitivityNCT04616404
The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia.
A study testing 500 mg of artichoke extract in people with Insulin Sensitivity and Obesity, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
Trial summary
Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Obesity, Overweight
- What is being tested?
- 500 mg of artichoke extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jul 2018to 5 Aug 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- without history of cardiovascular disease (CVD),
- not taking any medication likely to affect glucose or lipid metabolism (oral hypoglycemic agents and statins)
- free of overt liver, renal and thyroid disease
Who cannot join
- smoking
- drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda di Servizi alla Persona ''Istituto Santa Margherita''
Pavia, PV, 27100
About this study
Official title: The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia: a Double-blind, Placebo-controlled, Randomized Clinical Trial
Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycaemic control, insulin sensitivity and other metabolic parameters (total, HDL and LDL cholesterol, Triglycerides, ApoB, ApoA, waist circumference, Visceral adipose tissue by DXA) in overweight subjects with newly diagnosed IFG.
- Conditions
- Insulin Sensitivity, Obesity, Overweight
- Being tested
- 500 mg of artichoke extract, Placebo
- Keywords
- impaired fasting glucose, Cynara cardunculus, Insulin Sensitivity, Obesity, Overweight
- Medical subject headings
- Insulin Resistance, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500 mg of artichoke extractDietary supplement
Tablets containing 500 mg of artichoke extract (triple standardized to contain caffeoylquinic acids ≥ 5.0%; flavonoids ≥ 1.5%; cynaropicrin ≥ 1.0%, by HPLC)
PlaceboOther
Tablets with no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Not described Receives: Dietary Supplement: 500 mg of artichoke extract |
| Control Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on glycemia
Measured: Day 0, after 1 month and after 2 months
Secondary outcomes (8)
Changes on total cholesterol (mg/dl), HDL (mg/dl), total cholesterol/HLD, LDL (mg/dl), LDL/HDL, triglycerides (mg/dl), ApoA (mg/dl), ApoB (mg/dl), ApoB/ApoA, creatinine (mg/dl)
Measured: Day 0, after 1 month and after 2 months
Changes on AST (UI/l), ALT (UI/l), GGT (U/l)
Measured: Day 0, after 1 month and after 2 months
Changes on insulin (mcU/ml) and HOMA index
Measured: Day 0, after 1 month and after 2 months
Changes on glycated hemoglobin (%)
Measured: Day 0, after 1 month and after 2 months
Changes on A1c-Derived Average Glucose (mmol/l)
Measured: Day 0, after 1 month and after 2 months
Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg)
Measured: Day 0, after 1 month
Changes on waist circumference (cm)
Measured: Day 0, after 1 month
Changes on VAT (g), lean and fat mass (g)
Measured: Day 0, after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start26 Jul 2018
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin SensitivityStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Indena S.p.A
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616404
- Sponsor's protocol ID
- 9321/14122018
- Status last verified
- Oct 2020
- First submitted
- 13 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of Cynara Supplementation in Overweight and Obese Class I Subjects With Newly Detected Impaired Fasting Glycaemia: a Double-blind, Placebo-controlled, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04616404
- Acronym / sponsor ID
- 9321/14122018
- Conditions
- Insulin Sensitivity, Obesity, Overweight
- Keywords
- impaired fasting glucose, Cynara cardunculus, Insulin Sensitivity, Obesity, Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Collaborators
- Indena S.p.A
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 5 Nov 2020 (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.
Impaired fasting glucose (IFG) is a condition that precedes diabetes and increases the risk of developing it. Studies support the hypoglycemic effect of Cynara cardunculus (Cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. Given this background, we investigated whether a new highly standardized Cs extract could improve glycaemic control, insulin sensitivity and other metabolic parameters (total, HDL and LDL cholesterol, Triglycerides, ApoB, ApoA, waist circumference, Visceral adipose tissue by DXA) in overweight subjects with newly diagnosed IFG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Dietary Supplement: 500 mg of artichoke extract |
| Control Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- without history of cardiovascular disease (CVD),
- not taking any medication likely to affect glucose or lipid metabolism (oral hypoglycemic agents and statins)
- free of overt liver, renal and thyroid disease
Key exclusion criteria (2 listed)
- smoking
- drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)
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 |
|---|---|---|
| 500 mg of artichoke extractTablets containing 500 mg of artichoke extract (triple standardized to contain caffeoylquinic acids ≥ 5.0%; flavonoids ≥ 1.5%; cynaropicrin ≥ 1.0%, by HPLC) | Dietary supplement | Intervention Group |
| PlaceboTablets with no active ingredient | Other | Control Group |
Primary outcome
Changes on glycemia
Time frame: Day 0, after 1 month and after 2 months
8 secondary outcomes
Changes on total cholesterol (mg/dl), HDL (mg/dl), total cholesterol/HLD, LDL (mg/dl), LDL/HDL, triglycerides (mg/dl), ApoA (mg/dl), ApoB (mg/dl), ApoB/ApoA, creatinine (mg/dl)
Time frame: Day 0, after 1 month and after 2 months
Changes on AST (UI/l), ALT (UI/l), GGT (U/l)
Time frame: Day 0, after 1 month and after 2 months
Changes on insulin (mcU/ml) and HOMA index
Time frame: Day 0, after 1 month and after 2 months
Changes on glycated hemoglobin (%)
Time frame: Day 0, after 1 month and after 2 months
Changes on A1c-Derived Average Glucose (mmol/l)
Time frame: Day 0, after 1 month and after 2 months
Changes on maximum blood pressure (mmHg), minimum blood pressure (mmHg)
Time frame: Day 0, after 1 month
Changes on waist circumference (cm)
Time frame: Day 0, after 1 month
Changes on VAT (g), lean and fat mass (g)
Time frame: Day 0, after 1 month
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 5 Nov 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 500 mg of artichoke extract in people with Insulin Sensitivity and Obesity, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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 2 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 5 Nov 2020. 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 Italy. 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?
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?
Changes on glycemia (time frame: Day 0, after 1 month and after 2 months). 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 5 Nov 2020.