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Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia

2026年6月22日 更新者：Zhang Manna、Shanghai 10th People's Hospital

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200072
        • 招聘中
        • Shanghai Tenth People's Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Trial group (spermidine)
Spermidine capsules 10 mg/day
药品：Spermidine
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.
安慰剂比较：Control group (placebo)
Placebo 10 mg/day
药品：Placebo
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Triglycerides (TG)
大体时间：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.
Baseline and 1 month post-treatment

次要结果测量

结果测量
措施说明
大体时间
Three-Factor Eating Questionnaire - Revised 21-item(TFEQ-R21)
大体时间：Baseline and 1 month post-treatment
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.
Baseline and 1 month post-treatment
Alanine Aminotransferase
大体时间：Baseline and 1 month post-treatment
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.
Baseline and 1 month post-treatment
Fasting Blood Glucose
大体时间：Baseline and 1 month post-treatment
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.
Baseline and 1 month post-treatment
Low-Density Lipoprotein Cholesterol
大体时间：Baseline and 1 month post-treatment
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.
Baseline and 1 month post-treatment
Physical Activity Intensity
大体时间：Baseline and 1 month post-treatment
Physical activity levels (including intensity) were assessed using the short form of the International Physical Activity Questionnaire (IPAQ).
Baseline and 1 month post-treatment
Total Cholesterol (TC)
大体时间：Baseline and 1 month post-treatment
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.
Baseline and 1 month post-treatment
Creatinine
大体时间：Baseline and 1 month post-treatment
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.
Baseline and 1 month post-treatment
Body Weight
大体时间：Baseline and 1 month post-treatment
Body weight (kg) will be measured using a calibrated body composition scale.
Baseline and 1 month post-treatment
Body Fat Percentage
大体时间：Baseline and 1 month post-treatment
Body fat percentage(%) will be assessed using a body composition scale based on bioelectrical impedance analysis.
Baseline and 1 month post-treatment
Waist Circumference
大体时间：Baseline and 1 month post-treatment
Waist circumference(cm) will be measured at the midpoint between the lowest rib and the iliac crest using a standardized measuring tape.
Baseline and 1 month post-treatment
Hip Circumference
大体时间：Baseline and 1 month post-treatment
Hip circumference(cm) will be measured at the level of the greatest posterior protuberance of the buttocks using a standardized measuring tape.
Baseline and 1 month post-treatment
Body Mass Index (BMI)
大体时间：Baseline and 1 month post-treatment
BMI(kg/m²) will be calculated as body weight (kg) divided by height squared (m²).
Baseline and 1 month post-treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai 10th People's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年4月7日

首先提交符合 QC 标准的

2026年6月22日

首次发布 (实际的)

2026年6月23日

研究记录更新

最后更新发布 (实际的)

2026年6月23日

上次提交的符合 QC 标准的更新

2026年6月22日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Spermidine

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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