ObesityEarly Phase 1NCT06681597
Raspberry Ketone Intake Upregulates Circulating FGF21 and Induces Energy Expenditure in Humans
A Early Phase 1 study testing Raspberry ketone in people with Obesity and Diabetes, run by Nanchang University at 1 site in China.
Trial summary
To investigate the molecular mechanism of raspberry ketone on regulating obesity, the investigators studied the effect of raspberry ketone intake on FGF21 in plasma. The age of the volunteers were 18-60 years old, both male and female, without diabetes, hypertension and other diseases. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, NAFLD (Nonalcoholic Fatty Liver Disease)
- What is being tested?
- Raspberry ketone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 1 Jun 2024
- Phase
- Early Phase 1
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No drugs were taken before the human study
Who cannot join
- Patients with hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Raspberry Ketone Intake on Plasma FGF21 Levels
To investigate the molecular mechanism of raspberry ketone on regulating obesity, the investigators studied the effect of raspberry ketone intake on FGF21 in plasma.
The age of the volunteers were 18-60 years old, both male and female, without diabetes, hypertension and other diseases.
After ingestion of raspberry ketone (500mg), 2ml of blood was collected at 0 hours, 3 hours and 6 hours , and the FGF21 content in plasma was measured using a commercial reagent kit.
In addition, the investigators also studied the effect of raspberry ketone intake on energy metabolism 0 hours, 0.5 hours, 3 hours and 6 hours after consuming raspberry ketone (500mg).
- Conditions
- Obesity, Diabetes, NAFLD (Nonalcoholic Fatty Liver Disease)
- Being tested
- Raspberry ketone
- Medical subject headings
- Obesity, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raspberry ketoneDietary supplement
Human consumed 500mg of raspberry ketone
| Study group | Role | What they receive |
|---|---|---|
| Human administrated with raspberry ketone | Experimental | Not described Receives: Dietary Supplement: Raspberry ketone |
| Human administrated with placebo | Experimental | Not described Receives: Dietary Supplement: Raspberry ketone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of raspberry ketone consumption on plasma FGF21 level
Measured: Through study completion, an average of 1 year
Impact of raspberry ketone consumption on energy expenditure
The oxygen consumption, heart rate, carbon dioxide production were measured
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start10 Jan 2024
- Primary completion15 May 2024
- Study completion1 Jun 2024
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 ObesityStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Luo, Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681597
- Sponsor's protocol ID
- I-MRER [2023] No. 68
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez HL, Ziegenfuss TN, Hofheins JE, Habowski SM, Arent SM, Weir JP, Ferrando AA. Eight weeks of supplementation with a multi-ingredient weight loss product enhances body composition, reduces hip and waist girth, and increases energy levels in overweight men and women. J Int Soc Sports Nutr. 2013 Apr 19;10(1):22. doi: 10.1186/1550-2783-10-22.
PubMed 23601452
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Raspberry Ketone Intake on Plasma FGF21 Levels
- ClinicalTrials.gov ID
- NCT06681597
- Acronym / sponsor ID
- I-MRER [2023] No. 68
- Conditions
- Obesity, Diabetes, NAFLD (Nonalcoholic Fatty Liver Disease)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nanchang UniversityUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 8 Nov 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.
To investigate the molecular mechanism of raspberry ketone on regulating obesity, the investigators studied the effect of raspberry ketone intake on FGF21 in plasma.
The age of the volunteers were 18-60 years old, both male and female, without diabetes, hypertension and other diseases.
After ingestion of raspberry ketone (500mg), 2ml of blood was collected at 0 hours, 3 hours and 6 hours , and the FGF21 content in plasma was measured using a commercial reagent kit.
In addition, the investigators also studied the effect of raspberry ketone intake on energy metabolism 0 hours, 0.5 hours, 3 hours and 6 hours after consuming raspberry ketone (500mg).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human administrated with raspberry ketone | Experimental | Dietary Supplement: Raspberry ketone |
| Human administrated with placebo | Experimental | Dietary Supplement: Raspberry ketone |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- No drugs were taken before the human study
Key exclusion criteria (1 listed)
- Patients with hypertension
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 |
|---|---|---|
| Raspberry ketoneHuman consumed 500mg of raspberry ketone | Dietary supplement | Human administrated with placebo, Human administrated with raspberry ketone |
Primary outcome
Impact of raspberry ketone consumption on plasma FGF21 level
Time frame: Through study completion, an average of 1 year
Impact of raspberry ketone consumption on energy expenditure
Time frame: Through study completion, an average of 1 year
The oxygen consumption, heart rate, carbon dioxide production were measured
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 8 Nov 2024.
- Background: PubMed 23601452Lopez HL, Ziegenfuss TN, Hofheins JE, Habowski SM, Arent SM, Weir JP, Ferrando AA. Eight weeks of supplementation with a multi-ingredient weight loss product enhances body composition, reduces hip and waist girth, and increases energy levels in overweight men and women. J Int Soc Sports Nutr. 2013 Apr 19;10(1):22. doi: 10.1186/1550-2783-10-22.
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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 Early Phase 1 study testing Raspberry ketone in people with Obesity and Diabetes, run by Nanchang University at 1 site in China.
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 1 inclusion and 1 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 8 Nov 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Impact of raspberry ketone consumption on plasma FGF21 level (time frame: Through study completion, an average of 1 year). The study lists 2 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 NCT06681597, 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 8 Nov 2024.