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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 12g per day of salmon protein hydrolysate (SPH) for 56 days (8-weeks) | Experimental | 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 |
|
| 12g per day of whey protein isolate (WPI) for 56 days (8-weeks) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplementation | Other | ProGo is a proprietary mix of bioactive peptides. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin (g/L) | Change in serum hemoglobin level (g/L) from baseline to week 8 | Baseline (week 0), week 8 |
| Change in serum ferritin (mg/L) | Change in serum ferritin (micrograms/L) from baseline to end of study | Baseline (week 0), week 8 |
| Integumentary outcomes | 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. | 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body mass index (BMI) | Change in BMI (%) from baseline to end of study | Baseline (week 0), week 8 |
| Percentage change in body composition compartments | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Freddy Halvadar, PhD | GPH Biotech LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum Clinical Research | Mumbai | Maharashtra | 400020 | India |
Protection participant privacy.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Nutritional Supplement | Other | Standard whey protein |
|
| Baseline (week 0), week 8 |
| Change in glycated hemoglobin (HbA1c %) | Absolute change in glycated hemoglobin (HbA1c, %) from baseline to end of study | Baseline (week 0), week 8 |
| Change in fasting plasma glucose (mg/dL) | Absolute change in fasting plasma glucose (mg/dL) from baseline to end of study | Baseline (week 0), week 8 |
| Change in Inflammatory biomarkers | Change in plasma IL-6, IL-8, TNFa, IL-12B, IL-17 from baseline to end of study | Baseline (week 0), week 8 |
| Change in zonulin and gherlin | Assessment of change in markers of leaky gut and appetite from baseline to end of study | Baseline (week 0), week 8 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |