The Impact of Salmon Protein Hydrolysate (SPH / ProGo®) Supplementation on Hematologic and Metabolic Health
2026年5月26日 更新者：Hofseth Biocare ASA
A Randomized, Placebo-controlled, Double Blind Study to Evaluate the Impact of ProGo® Supplementation on Hematologic and Metabolic Health Markers in Healthy Adults
Healthy, overweight males and females randomised to receive 8-weeks of salmon protein hydrolysate SPH (12g daily) or whey protein isolate (12g daily) to assess the impact on red blood cell and ferritin levels, blood glucose levels, BMI, percent body fat and lean body mass along with hair, skin and nail health and blood biomarkers of inflammation.
研究概览
详细说明
This randomised, double-blinded study assessed the impact of 8-weeks of salmon protein hydrolysate SPH (12g daily) or whey protein isolate (12g daily) on important biomarkers of health and longevity.
Changes in complete blood count and ferritin will assess improvements in iron metabolism and change in fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) glucose metabolism assessed via blood draw.
Change in hair, nail and skin quality assessed by questionnaire and change in body profile assessments by bioelectrical impedance analysis (BIA) to assess change in body fat, lean mass and body water along with measurements of hip and waist circumference.
Inflammatory biomarkers assessed via blood draw along with fasting gherlin (impact on appetite) and zonulin (gut health / leaky gut biomarker).
研究类型
介入性
注册 (实际的)
14
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。
学习地点
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Maharashtra
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Mumbai、Maharashtra、印度、400020
- Spectrum Clinical Research
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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
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Subjects that have provided written and dated informed consent.
- Subjects that are in good health as determined by self-declared medical history and physical examination.
- Subjects that are male or female between the ages of 25 and 65 (inclusive).
- Subjects that have a Body Mass Index of 25-35.
- Subjects that are willing and able to comply with the supplement protocol.
- Subject who is willing and able to comply with the supplement intake regimen, lab visits schedule and weekly telephone follow up calls .
Exclusion Criteria:
- Subjects that currently hyper exercise defined as 3 hours or more for more than five times per week.
- Subjects that have used weight loss medications within the past one month of the Screening visit.
- Subjects that self-declare a known previous diagnosis of alcohol or substance abuse or have electrolyte abnormalities, thyroid, diabetes, hypogonadism, hepato-renal, musculoskeletal, autoimmune, neurologic, psychiatric disorders, or cancer which are under active drug treatment.
- Subjects who self-declare to having a peptic ulcer or active IBS under daily prescription drug treatment.
- Subjects who are self-declared to be pregnant, trying to become pregnant, or who are nursing or who are less than 6 months postpartum at enrollment.
- Subject that has been hospitalized within the past one-year for any mental or emotional illness.
- Subjects who have an active infection or sign/symptoms of an infection.
- Subjects who have a known allergy to any of the ingredients in any of the test products.
- Subjects that have a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：12g per day of salmon protein hydrolysate (SPH) for 56 days (8-weeks)
SPH is a highly soluble mix of small peptides derived from Norwegian Atlantic salmon via a proprietary enzymatic hydrolysis process using natural, non-GMO protease enzymes
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ProGo is a proprietary mix of bioactive peptides.
其他名称：
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有源比较器：12g per day of whey protein isolate (WPI) for 56 days (8-weeks)
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Standard whey protein
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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 |
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Change in hemoglobin (g/L)
大体时间：Baseline (week 0), week 8
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Change in serum hemoglobin level (g/L) from baseline to week 8
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Baseline (week 0), week 8
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Change in serum ferritin (mg/L)
大体时间：Baseline (week 0), week 8
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Change in serum ferritin (micrograms/L) from baseline to end of study
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Baseline (week 0), week 8
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Integumentary outcomes
大体时间：8-weeks
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Change in perceived hair, nail and skin quality assessed by self-assessment questionnaire consisting of seven items evaluating hair volume, hair softness, hair shine, hair strength, nail strength, skin hydration, and overall skin health administered at baseline and on day 56.
Each item is rated on a 6-point Likert scale ranging from 1 ("greatly satisfied") to 6 ("greatly dissatisfied"), with lower scores indicating more favorable outcomes.
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8-weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Body mass index (BMI)
大体时间：Baseline (week 0), week 8
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Change in BMI (%) from baseline to end of study
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Baseline (week 0), week 8
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Percentage change in body composition compartments
大体时间：Baseline (week 0), week 8
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Body composition assessed using the InBody 570, a multi-frequency bioelectrical impedance analysis (BIA) device (InBody, Cerritos, CA, USA), providing a calculation of percentage of body fat, percentage of lean body mass and percentage of body water.
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Baseline (week 0), week 8
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Change in glycated hemoglobin (HbA1c %)
大体时间：Baseline (week 0), week 8
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Absolute change in glycated hemoglobin (HbA1c, %) from baseline to end of study
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Baseline (week 0), week 8
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Change in fasting plasma glucose (mg/dL)
大体时间：Baseline (week 0), week 8
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Absolute change in fasting plasma glucose (mg/dL) from baseline to end of study
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Baseline (week 0), week 8
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Change in Inflammatory biomarkers
大体时间：Baseline (week 0), week 8
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Change in plasma IL-6, IL-8, TNFa, IL-12B, IL-17 from baseline to end of study
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Baseline (week 0), week 8
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Change in zonulin and gherlin
大体时间：Baseline (week 0), week 8
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Assessment of change in markers of leaky gut and appetite from baseline to end of study
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Baseline (week 0), week 8
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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。
调查人员
- 首席研究员：Freddy Halvadar, PhD、GPH Biotech LLC
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)
2019年7月19日
初级完成 (实际的)
2019年11月3日
研究完成 (实际的)
2020年1月3日
研究注册日期
首次提交
2026年5月14日
首先提交符合 QC 标准的
2026年5月26日
首次发布 (实际的)
2026年6月1日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月26日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.