Obesity & OverweightNCT07662330
Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia
A study testing Spermidine in people with Obesity & Overweight and Hyperlipidemia, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Evaluate the effect of spermidine supplementation on lipid profile changes in individuals with overweight or obesity accompanied by hyperlipidemia. Analyze the impact of spermidine on metabolic parameters and assess the safety of spermidine supplementation, including liver and kidney function, gastrointestinal… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity & Overweight, Hyperlipidemia
- What is being tested?
- Spermidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females aged 18 to 65 years.
- BMI ≥ 24 kg/m², without severe chronic diseases.
- Not currently using glucose-lowering or lipid-lowering medications.
- Dyslipidemia defined as triglycerides ≥ 1.7 mmol/L or total cholesterol ≥ 5.2 mmol/L.
- No active weight loss or weight gain diet within the past 1 month.
- No special dietary pattern changes (e.g., ketogenic, vegan, high-protein, meal replacement, intermittent fasting) within the past 1 month.
- No use of supplements that may affect polyamine intake (e.g., germ, yeast, fermented extracts, nutritional powders) within the past 2-4 weeks.
- Willing and able to provide signed informed consent.
Who cannot join
- Diagnosis of acute or severe gastrointestinal disease
- Concurrent participation in any other weight-loss therapy
- Current use of hypoglycemic or lipid-lowering medications
- Participation in any other clinical trial within one month prior to signing the informed consent form
- Pregnancy, lactation, or planning a pregnancy during the trial period
- Known allergy to cellulose or wheat
Show all 10Show fewer
- History of cancer
- Renal insufficiency, indicated by abnormal serum creatinine levels
- Hepatic impairment, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN), or total bilirubin (TBIL) >3 × ULN
- Any other condition deemed by the investigator as inappropriate for trial participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People'S Hospital
Shanghai, Shanghai Municipality, 200072
Bu Le, +86 17701621016, geyingjun@hotmail.com
About this study
Official title: Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia: A Randomized, Double-Blind, Placebo-Controlled Trial
Evaluate the effect of spermidine supplementation on lipid profile changes in individuals with overweight or obesity accompanied by hyperlipidemia. Analyze the impact of spermidine on metabolic parameters and assess the safety of spermidine supplementation, including liver and kidney function, gastrointestinal reactions, and other adverse effects.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of spermidine supplementation in overweight or obese adults with hyperlipidemia.
A total of 50 eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group (spermidine capsule 10 mg/day) or the control group (placebo capsule, identical in appearance, packaging, and taste). Randomization will be performed by a third-party statistician using a computer-generated random number table with variable block sizes. Allocation concealment will be ensured through sequentially numbered, opaque, sealed envelopes. All outcome assessors, investigators, and participants will be blinded to group assignment throughout the study.
The intervention period lasts 1 month. Participants in the experimental group will take 2 capsules (10 mg total) of spermidine (extracted from North American high-selenium wheat germ, 100:1 concentration process) orally per day after breakfast. The placebo group will receive an identical regimen of microcrystalline cellulose capsules. During the trial, all participants will receive standardized dietary advice designed to avoid high-polyamine foods (e.g., natto, fermented soy products, mushroom, germ products) and maintain stable total energy intake without overeating. They will also be advised to avoid new nutritional supplements and any other weight-loss interventions. Weekly telephone follow-ups will monitor compliance and dietary/exercise logs. Compliance will be assessed by pill counts of returned capsules, with <80% adherence defined as protocol deviation.
Assessments are scheduled at baseline (Day 0) and at study end (Month 1). Baseline evaluations include anthropometric measurements, blood biochemistry, stool sample collection, and questionnaire assessments. At Month 1, all baseline measurements will be repeated, and adverse events will be recorded and assessed for causality using the Naranjo scale. Safety monitoring includes liver and kidney function tests and documentation of gastrointestinal or other adverse reactions throughout the trial.
Primary outcome is the change in triglycerides (TG) from baseline to 1 month. Secondary outcomes include changes in LDL, total cholesterol, weight, BMI, body fat percentage, waist-to-hip ratio, fasting glucose, liver/kidney function parameters, and adverse event rates. Statistical analyses will follow the intention-to-treat principle using SAS 9.4. Primary analysis will employ two independent sample t-tests or Mann-Whitney U tests for between-group comparisons.
- Conditions
- Obesity & Overweight, Hyperlipidemia
- Being tested
- Spermidine, Placebo
- Medical subject headings
- Obesity, Overweight, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpermidineDrug
Spermidine (10 mg/day) administered as two oral capsules taken after breakfast. The spermidine is extracted from North American high-selenium wheat germ using a 100:1 concentration process. Each capsule contains 5 mg of spermidine, with a total daily dose of 10 mg. The intervention duration is 1 month.
PlaceboDrug
Placebo capsules are identical in appearance, color, size, packaging, and taste to the spermidine capsules. Each capsule is filled with microcrystalline cellulose and contains no active ingredients. Participants will take two placebo capsules orally after breakfast daily for a duration of 1 month. The placebo is packaged and blinded by an independent pharmacy according to a randomization code to ensure double-blind implementation.
| Study group | Role | What they receive |
|---|---|---|
| Trial group (spermidine) | Experimental | Spermidine capsules 10 mg/day Receives: Drug: Spermidine |
| Control group (placebo) | Placebo comparator | Placebo 10 mg/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides (TG)
Change in fasting serum triglycerides (TG) from baseline (Day 0) to the end of the 1-month intervention period. Blood samples are collected after an overnight fast and analyzed using standard enzymatic methods. TG level is measured in mmol/L. This is the primary efficacy outcome of the study.
Measured: Baseline and 1 month post-treatment
Secondary outcomes (12)
Three-Factor Eating Questionnaire - Revised 21-item(TFEQ-R21)
The Three-Factor Eating Questionnaire-Revised 21-item (TFEQ-R21) is a validated instrument assessing eating behaviors across three domains: cognitive restraint, uncontrolled eating, and emotional eating. The questionnaire consists of 21 items scored on a 4-point Likert scale, yielding a total score ranging from 21 to 84, or standardized scores from 0 to 100. Higher scores indicate greater levels of the respective eating behavior, with higher uncontrolled and emotional eating scores reflecting more dysfunctional eating patterns.
Measured: Baseline and 1 month post-treatment
Alanine Aminotransferase
Change in serum alanine aminotransferase (ALT) levels from baseline (Day 0) to 1 month post-treatment (Month 1). Blood samples are collected after an overnight fast and analyzed using standard enzymatic methods. ALT is measured in U/L and serves as a safety indicator of liver function.
Measured: Baseline and 1 month post-treatment
Fasting Blood Glucose
Change in fasting blood glucose levels from baseline (Day 0) to 1 month post-treatment (Month 1). Blood samples are collected after an overnight fast and analyzed using standard glucose oxidase or hexokinase methods. Fasting blood glucose is measured in mmol/L.
Measured: Baseline and 1 month post-treatment
Low-Density Lipoprotein Cholesterol
Change in serum low-density lipoprotein cholesterol (LDL-C) levels from baseline (Day 0) to 1 month post-treatment (Month 1). Blood samples are collected after an overnight fast and analyzed using standard enzymatic or homogeneous direct methods. LDL-C is measured in mmol/L.
Measured: Baseline and 1 month post-treatment
Physical Activity Intensity
Physical activity levels (including intensity) were assessed using the short form of the International Physical Activity Questionnaire (IPAQ).
Measured: Baseline and 1 month post-treatment
Total Cholesterol (TC)
Change in serum total cholesterol (TC) levels from baseline (Day 0) to 1 month post-treatment (Month 1). Blood samples are collected after an overnight fast and analyzed using standard enzymatic methods (cholesterol oxidase-peroxidase method). TC is measured in mmol/L.
Measured: Baseline and 1 month post-treatment
Creatinine
Change in serum creatinine levels from baseline (Day 0) to 1 month post-treatment (Month 1). Blood samples are collected after an overnight fast and analyzed using standard enzymatic or Jaffé methods. Creatinine is measured in μmol/L or mg/dL and serves as a safety indicator of renal function.
Measured: Baseline and 1 month post-treatment
Body Weight
Body weight (kg) will be measured using a calibrated body composition scale.
Measured: Baseline and 1 month post-treatment
Body Fat Percentage
Body fat percentage(%) will be assessed using a body composition scale based on bioelectrical impedance analysis.
Measured: Baseline and 1 month post-treatment
Waist Circumference
Waist circumference(cm) will be measured at the midpoint between the lowest rib and the iliac crest using a standardized measuring tape.
Measured: Baseline and 1 month post-treatment
Hip Circumference
Hip circumference(cm) will be measured at the level of the greatest posterior protuberance of the buttocks using a standardized measuring tape.
Measured: Baseline and 1 month post-treatment
Body Mass Index (BMI)
BMI(kg/m²) will be calculated as body weight (kg) divided by height squared (m²).
Measured: Baseline and 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662330
- Sponsor's protocol ID
- Spermidine
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07662330
- Acronym / sponsor ID
- Spermidine
- Conditions
- Obesity & Overweight, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 23 Jun 2026 (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.
Evaluate the effect of spermidine supplementation on lipid profile changes in individuals with overweight or obesity accompanied by hyperlipidemia. Analyze the impact of spermidine on metabolic parameters and assess the safety of spermidine supplementation, including liver and kidney function, gastrointestinal reactions, and other adverse effects.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of spermidine supplementation in overweight or obese adults with hyperlipidemia.
A total of 50 eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group (spermidine capsule 10 mg/day) or the control group (placebo capsule, identical in appearance, packaging, and taste). Randomization will be performed by a third-party statistician using a computer-generated random number table with variable block sizes. Allocation concealment will be ensured through sequentially numbered, opaque, sealed envelopes. All outcome assessors, investigators, and participants will be blinded to group assignment throughout the study.
The intervention period lasts 1 month. Participants in the experimental group will take 2 capsules (10 mg total) of spermidine (extracted from North American high-selenium wheat germ, 100:1 concentration process) orally per day after breakfast. The placebo group will receive an identical regimen of microcrystalline cellulose capsules. During the trial, all participants will receive standardized dietary advice designed to avoid high-polyamine foods (e.g., natto, fermented soy products, mushroom, germ products) and maintain stable total energy intake without overeating. They will also be advised to avoid new nutritional supplements and any other weight-loss interventions. Weekly telephone follow-ups will monitor compliance and dietary/exercise logs. Compliance will be assessed by pill counts of returned capsules, with <80% adherence defined as protocol deviation.
Assessments are scheduled at baseline (Day 0) and at study end (Month 1). Baseline evaluations include anthropometric measurements, blood biochemistry, stool sample collection, and questionnaire assessments. At Month 1, all baseline measurements will be repeated, and adverse events will be recorded and assessed for causality using the Naranjo scale. Safety monitoring includes liver and kidney function tests and documentation of gastrointestinal or other adverse reactions throughout the trial.
Primary outcome is the change in triglycerides (TG) from baseline to 1 month. Secondary outcomes include changes in LDL, total cholesterol, weight, BMI, body fat percentage, waist-to-hip ratio, fasting glucose, liver/kidney function parameters, and adverse event rates. Statistical analyses will follow the intention-to-treat principle using SAS 9.4. Primary analysis will employ two independent sample t-tests or Mann-Whitney U tests for between-group comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group (spermidine) | Experimental | Drug: SpermidineSpermidine capsules 10 mg/day |
| Control group (placebo) | Placebo comparator | Drug: PlaceboPlacebo 10 mg/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males or females aged 18 to 65 years.
- BMI ≥ 24 kg/m², without severe chronic diseases.
- Not currently using glucose-lowering or lipid-lowering medications.
- Dyslipidemia defined as triglycerides ≥ 1.7 mmol/L or total cholesterol ≥ 5.2 mmol/L.
- No active weight loss or weight gain diet within the past 1 month.
Key exclusion criteria (10 listed)
- Diagnosis of acute or severe gastrointestinal disease
- Concurrent participation in any other weight-loss therapy
- Current use of hypoglycemic or lipid-lowering medications
- Participation in any other clinical trial within one month prior to signing the informed consent form
- Pregnancy, lactation, or planning a pregnancy during the trial period
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 |
|---|---|---|
| SpermidineSpermidine (10 mg/day) administered as two oral capsules taken after breakfast. The spermidine is extracted from North American high-selenium wheat germ using a 100:1 concentration process. Each capsule contains 5 mg of spermidine, with a total daily dose of 10 mg. The intervention duration is 1 month. | Drug | Trial group (spermidine) |
| PlaceboPlacebo capsules are identical in appearance, color, size, packaging, and taste to the spermidine capsules. Each capsule is filled with microcrystalline cellulose and contains no active ingredients. Participants will take two placebo capsules orally after breakfast daily for a duration of 1 month. The placebo is packaged and blinded by an independent pharmacy according to a randomization code to ensure double-blind implementation. | Drug | Control group (placebo) |
Primary outcome
Triglycerides (TG)
Time frame: Baseline and 1 month post-treatment
Change in fasting serum triglycerides (TG) from baseline (Day 0) to the end of the 1-month intervention period. Blood samples are collected after an overnight fast and analyzed using standard enzymatic methods. TG level is measured in mmol/L. This is the primary efficacy outcome of the study.
12 secondary outcomes
Three-Factor Eating Questionnaire - Revised 21-item(TFEQ-R21)
Time frame: Baseline and 1 month post-treatment
Alanine Aminotransferase
Time frame: Baseline and 1 month post-treatment
Fasting Blood Glucose
Time frame: Baseline and 1 month post-treatment
Low-Density Lipoprotein Cholesterol
Time frame: Baseline and 1 month post-treatment
Physical Activity Intensity
Time frame: Baseline and 1 month post-treatment
Total Cholesterol (TC)
Time frame: Baseline and 1 month post-treatment
Creatinine
Time frame: Baseline and 1 month post-treatment
Body Weight
Time frame: Baseline and 1 month post-treatment
Body Fat Percentage
Time frame: Baseline and 1 month post-treatment
Waist Circumference
Time frame: Baseline and 1 month post-treatment
Hip Circumference
Time frame: Baseline and 1 month post-treatment
Body Mass Index (BMI)
Time frame: Baseline and 1 month post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spermidine in people with Obesity & Overweight and Hyperlipidemia, run by Shanghai 10th People's Hospital 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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bu Le (+86 17701621016, geyingjun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglycerides (TG) (time frame: Baseline and 1 month post-treatment). 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 23 Jun 2026.