Assessment of the Effects and Safety of Spermidine Supplementation on Blood Lipids and Body Weight in Overweight or Obese Individuals With Hyperlipidemia
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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Bu Le
- 電話番号：+86 17701621016
- メール：geyingjun@hotmail.com
研究場所
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200072
- 募集
- Shanghai Tenth People's Hospital
-
コンタクト：
- Bu Le
- 電話番号：+86 17701621016
- メール：geyingjun@hotmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Trial group (spermidine)
Spermidine capsules 10 mg/day
|
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.
|
|
プラセボコンパレーター：Control group (placebo)
Placebo 10 mg/day
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Triglycerides (TG)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Three-Factor Eating Questionnaire - Revised 21-item(TFEQ-R21)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。