ObesityNCT06057389
The Effects of Aronia Melanocarpa Extract on Obese Individuals With Impaired Fasting Blood Glucose
A study testing aronia melanocarpa extract in people with Obesity, run by Peking Union Medical College Hospital.
Trial summary
Obesity is closely related to many chronic diseases such as hypertension, coronary heart disease, hyperlipidemia, type 2 diabetes, fatty liver, certain types of tumors, etc, which are associated with adverse health outcomes. Limiting energy intake is one of the most important treatment measures for weight loss. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity
- What is being tested?
- aronia melanocarpa extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2023to 30 Dec 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-40 years
- Simple obese individuals with stable body weight in the last three months before enrollment (28.0kg/m2 ≤ BMI <35.0kg/m2)
- Impaired fasting blood glucose: Within the last three months before enrollment, the venous fasting blood glucose was between 6.1 and 7.0 mmol/L, and the 2-hour postprandial blood glucose was<7.8 mmol/L and the glycated hemoglobin (HbA1c) was < 6.5%
Who cannot join
- Diagnosed patients with diabetes or those who use hypoglycemic drugs
- Patients with concomitant hyperthyroidism or hypothyroidism, or those taking thyroxine tablets
- Those who apply glucocorticoids within 12 weeks
- Individuals with suspected renal dysfunction (female: serum creatinine ≥ 84 µ mol/L; male: serum creatinine ≥ 104 µ mol/L) or suspected liver dysfunction (elevated transaminase >3 times normal or cirrhosis)
- Secondary obesity (such as thalamic diseases, pituitary diseases, Cushing's syndrome, etc.)
- Previous weight loss surgeries
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- Pregnant or lactating individuals
- Individuals with confirmed mental illness or eating disorders
- Women with polycystic ovary syndrome
- Individuals who are allergic or intolerant to experimental products
- Lactose intolerant individuals
- Those who have taken probiotics and/or probiotic drugs or supplements within one month before enrollment
- Those who fail to use intervention agents according to the study protocol or have severely incomplete visit records
About this study
Official title: The Effects of Black Aronia Melanocarpa Extract Combined With a Energy-restricted Diet on Metabolic Indicators and Intestinal Microecology in Obese Individuals With Impaired Fasting Blood Glucose
Obesity is closely related to many chronic diseases such as hypertension, coronary heart disease, hyperlipidemia, type 2 diabetes, fatty liver, certain types of tumors, etc, which are associated with adverse health outcomes. Limiting energy intake is one of the most important treatment measures for weight loss. The fruits of Aronia melanocarpa (Aronia berries) have been found to show multiple bioactivities potentially beneficial to human health, including antidiabetic, anti-infective, antineoplastic, antiobesity, antioxidant and gut microbiota-regulating activities. Thus, it is worth investigating whether consumption of aronia melanocarpa extract have additional benefits in improving anthropometric indicators, glucose and lipid metabolism, inflammatory status, adipocyte cytokines, and intestinal microbiota in obese individuals on the basis of an energy-restricted diet.
Obese individuals will be divided into intervention group and control group in this 8-week trial. Both groups will be given an energy-restricted diet, with an additional dose of aronia melanocarpa extract in capsules in intervention group and an additional dose of maltodextrin in capsules in control group.
Fecal and blood samples from participants before and after the intervention will be collected for the analysis of gut microbiota, glucose and lipid metabolism, inflammatory status, and adipocyte cytokines
- Conditions
- Obesity
- Being tested
- aronia melanocarpa extract
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aronia melanocarpa extractDietary supplement
aronia melanocarpa extract (each capsule contains 150 mg of anthocyanins and 30 mg of flavonoidst；twice a day，one at a time) combined with an energy-restricted diet
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Intervention group: an energy-restricted diet + aronia melanocarpa extract Receives: Dietary Supplement: aronia melanocarpa extract |
| Control group | Placebo comparator | control group: an energy-restricted diet + maltodextrin Receives: Dietary Supplement: aronia melanocarpa extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota
High flux sequencing of fecal specimens
Measured: 8 weeks
glucose metabolism
Fasting blood glucose (in mmol/L)
Measured: 8 weeks
glucose metabolism
fasting insulin (in μIU/L)
Measured: 8 weeks
glucose metabolism
glycosylated hemoglobin (in %)
Measured: 8 weeks
lipid metabolism
total cholesterol (in mmol/L)
Measured: 8 weeks
lipid metabolism
triglycerides (in mmol/L)
Measured: 8 weeks
lipid metabolism
high-density lipoprotein cholesterol (in mmol/L)
Measured: 8 weeks
lipid metabolism
low-density lipoprotein cholesterol (in mmol/L)
Measured: 8 weeks
leptin
serum leptin (in ng/ml)
Measured: 8 weeks
adiponectin
serum adiponectin (in μg/ml)
Measured: 8 weeks
Inflammatory cytokine
serum interleukin-1 (in pg/mL)
Measured: 8 weeks
Inflammatory cytokine
serum interleukin-6 (in ng/L)
Measured: 8 weeks
Inflammatory cytokine
tumor necrosis factor-α (in pg/ml)
Measured: 8 weeks
Inflammatory cytokine
hypersensitive C-reactive protein (in mg/L)
Measured: 8 weeks
Secondary outcomes (4)
Anthropometrics
Body weight (in kg)
Measured: 8 weeks
Anthropometrics
waist circumference (in cm)
Measured: 8 weeks
Anthropometrics
BMI in kg/m^2
Measured: 8 weeks
body composition
including body fat (in %), fat-free mass (in kg)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start7 Oct 2023 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057389
- Sponsor's protocol ID
- I-23PJ329
- Status last verified
- Sep 2023
- First submitted
- 14 Sep 2023
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Black Aronia Melanocarpa Extract Combined With a Energy-restricted Diet on Metabolic Indicators and Intestinal Microecology in Obese Individuals With Impaired Fasting Blood Glucose
- ClinicalTrials.gov ID
- NCT06057389
- Acronym / sponsor ID
- I-23PJ329
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 7 Oct 2023 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Sep 2023 (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.
Obesity is closely related to many chronic diseases such as hypertension, coronary heart disease, hyperlipidemia, type 2 diabetes, fatty liver, certain types of tumors, etc, which are associated with adverse health outcomes. Limiting energy intake is one of the most important treatment measures for weight loss. The fruits of Aronia melanocarpa (Aronia berries) have been found to show multiple bioactivities potentially beneficial to human health, including antidiabetic, anti-infective, antineoplastic, antiobesity, antioxidant and gut microbiota-regulating activities. Thus, it is worth investigating whether consumption of aronia melanocarpa extract have additional benefits in improving anthropometric indicators, glucose and lipid metabolism, inflammatory status, adipocyte cytokines, and intestinal microbiota in obese individuals on the basis of an energy-restricted diet.
Obese individuals will be divided into intervention group and control group in this 8-week trial. Both groups will be given an energy-restricted diet, with an additional dose of aronia melanocarpa extract in capsules in intervention group and an additional dose of maltodextrin in capsules in control group.
Fecal and blood samples from participants before and after the intervention will be collected for the analysis of gut microbiota, glucose and lipid metabolism, inflammatory status, and adipocyte cytokines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: aronia melanocarpa extractIntervention group: an energy-restricted diet + aronia melanocarpa extract |
| Control group | Placebo comparator | Dietary Supplement: aronia melanocarpa extractcontrol group: an energy-restricted diet + maltodextrin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-40 years
- Simple obese individuals with stable body weight in the last three months before enrollment (28.0kg/m2 ≤ BMI <35.0kg/m2)
- Impaired fasting blood glucose: Within the last three months before enrollment, the venous fasting blood glucose was between 6.1 and 7.0 mmol/L, and the 2-hour postprandial blood glucose was<7.8 mmol/L and the glycated hemoglobin (HbA1c) was < 6.5%
Key exclusion criteria (13 listed)
- Diagnosed patients with diabetes or those who use hypoglycemic drugs
- Patients with concomitant hyperthyroidism or hypothyroidism, or those taking thyroxine tablets
- Those who apply glucocorticoids within 12 weeks
- Individuals with suspected renal dysfunction (female: serum creatinine ≥ 84 µ mol/L; male: serum creatinine ≥ 104 µ mol/L) or suspected liver dysfunction (elevated transaminase >3 times normal or cirrhosis)
- Secondary obesity (such as thalamic diseases, pituitary diseases, Cushing's syndrome, etc.)
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 |
|---|---|---|
| aronia melanocarpa extractaronia melanocarpa extract (each capsule contains 150 mg of anthocyanins and 30 mg of flavonoidst；twice a day，one at a time) combined with an energy-restricted diet | Dietary supplement | Control group, Intervention group |
Primary outcome
gut microbiota
Time frame: 8 weeks
High flux sequencing of fecal specimens
glucose metabolism
Time frame: 8 weeks
Fasting blood glucose (in mmol/L)
glucose metabolism
Time frame: 8 weeks
fasting insulin (in μIU/L)
glucose metabolism
Time frame: 8 weeks
glycosylated hemoglobin (in %)
lipid metabolism
Time frame: 8 weeks
total cholesterol (in mmol/L)
lipid metabolism
Time frame: 8 weeks
triglycerides (in mmol/L)
lipid metabolism
Time frame: 8 weeks
high-density lipoprotein cholesterol (in mmol/L)
lipid metabolism
Time frame: 8 weeks
low-density lipoprotein cholesterol (in mmol/L)
leptin
Time frame: 8 weeks
serum leptin (in ng/ml)
adiponectin
Time frame: 8 weeks
serum adiponectin (in μg/ml)
Inflammatory cytokine
Time frame: 8 weeks
serum interleukin-1 (in pg/mL)
Inflammatory cytokine
Time frame: 8 weeks
serum interleukin-6 (in ng/L)
Inflammatory cytokine
Time frame: 8 weeks
tumor necrosis factor-α (in pg/ml)
Inflammatory cytokine
Time frame: 8 weeks
hypersensitive C-reactive protein (in mg/L)
4 secondary outcomes
Anthropometrics
Time frame: 8 weeks
Anthropometrics
Time frame: 8 weeks
Anthropometrics
Time frame: 8 weeks
body composition
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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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 aronia melanocarpa extract in people with Obesity, run by Peking Union Medical College Hospital.
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 13 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 28 Sep 2023. 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?
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?
gut microbiota (time frame: 8 weeks). The study lists 14 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 28 Sep 2023.