A Randomized, Placebo-controlled, Double Blind Study to Evaluate the Impact of ProGo® Supplementation on Hematologic and Metabolic Health Markers in Healthy Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hofseth Biocare ASA
- Enrollment
- 14
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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-
- •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.