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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

22 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Porcelana
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200072
        • Reclutamiento
        • Shanghai Tenth People's Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Trial group (spermidine)
Spermidine capsules 10 mg/day
Droga: 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.
Comparador de placebos: Control group (placebo)
Placebo 10 mg/day
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Triglycerides (TG)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Three-Factor Eating Questionnaire - Revised 21-item(TFEQ-R21)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Shanghai 10th People's Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de enero de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

7 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de junio de 2026

Publicado por primera vez (Actual)

23 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de junio de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Spermidine

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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