Overweight (BMI > 25), Weight Loss
Conditions
Keywords
Body mass index, Overweight, Salmon protein hydrolysate
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).
Interventions
ProGo is a proprietary mix of bioactive peptides.
OTHERNutritional Supplement
Standard whey protein
Sponsors
Hofseth Biocare ASA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
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 25-35. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin (g/L) | Baseline (week 0), week 8 | Change in serum hemoglobin level (g/L) from baseline to week 8 |
| Change in serum ferritin (mg/L) | Baseline (week 0), week 8 | Change in serum ferritin (micrograms/L) from baseline to end of study |
| Integumentary outcomes | 8-weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body mass index (BMI) | Baseline (week 0), week 8 | Change in BMI (%) from baseline to end of study |
| Percentage change in body composition compartments | Baseline (week 0), week 8 | 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. |
| Change in glycated hemoglobin (HbA1c %) | Baseline (week 0), week 8 | Absolute change in glycated hemoglobin (HbA1c, %) from baseline to end of study |
| Change in fasting plasma glucose (mg/dL) | Baseline (week 0), week 8 | Absolute change in fasting plasma glucose (mg/dL) from baseline to end of study |
| Change in Inflammatory biomarkers | Baseline (week 0), week 8 | Change in plasma IL-6, IL-8, TNFa, IL-12B, IL-17 from baseline to end of study |
| Change in zonulin and gherlin | Baseline (week 0), week 8 | Assessment of change in markers of leaky gut and appetite from baseline to end of study |
Countries
India
Contacts
PRINCIPAL_INVESTIGATORFreddy Halvadar, PhD
GPH Biotech LLC
Outcome results
None listed