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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 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

Studieorter

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200072
        • Rekrytering
        • Shanghai Tenth People's Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Trial group (spermidine)
Spermidine capsules 10 mg/day
Läkemedel: 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.
Placebo-jämförare: Control group (placebo)
Placebo 10 mg/day
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Triglycerides (TG)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Three-Factor Eating Questionnaire - Revised 21-item(TFEQ-R21)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Shanghai 10th People's Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2026

Primärt slutförande (Beräknad)

31 december 2026

Avslutad studie (Beräknad)

31 januari 2027

Studieregistreringsdatum

Först inskickad

7 april 2026

Först inskickad som uppfyllde QC-kriterierna

22 juni 2026

Första postat (Faktisk)

23 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juni 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Spermidine

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NEJ

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