The Impact of Salmon Protein Hydrolysate (SPH / ProGo®) Supplementation on Hematologic and Metabolic Health

Hofseth Biocare

Status: Completed

Conditions: Weight Loss; Overweight (BMI > 25)

Treatments: Other: Nutritional supplementation; Other: Nutritional Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT07616752

SPH001-19

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 14 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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14 participants in 2 patient groups

12g per day of salmon protein hydrolysate (SPH) for 56 days (8-weeks)

Experimental group

Description:

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

Treatment:

Other: Nutritional supplementation

12g per day of whey protein isolate (WPI) for 56 days (8-weeks)

Active Comparator group

Treatment:

Other: Nutritional Supplement