Spectrum Clinical Research
Mumbai, Maharashtra, 400020, India
NCT Number: NCT07616752
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.
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Notify Me25 year–65 year
All sexes
Interventional
Not applicable
Mumbai, Maharashtra, 400020, India
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ProGo is a proprietary mix of bioactive peptides.
Other names: ProGo
Standard whey protein
Time frame: Baseline (week 0), week 8
Change in serum hemoglobin level (g/L) from baseline to week 8
Time frame: Baseline (week 0), week 8
Change in serum ferritin (micrograms/L) from baseline to end of study
Time frame: 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.
Time frame: Baseline (week 0), week 8
Change in BMI (%) from baseline to end of study
Time frame: 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.
Time frame: Baseline (week 0), week 8
Absolute change in glycated hemoglobin (HbA1c, %) from baseline to end of study
Time frame: Baseline (week 0), week 8
Absolute change in fasting plasma glucose (mg/dL) from baseline to end of study
Time frame: Baseline (week 0), week 8
Change in plasma IL-6, IL-8, TNFa, IL-12B, IL-17 from baseline to end of study
Time frame: Baseline (week 0), week 8
Assessment of change in markers of leaky gut and appetite from baseline to end of study
Hofseth Biocare ASA
Industry
A Randomized, Placebo-controlled, Double Blind Study to Evaluate the Impact of ProGo® Supplementation on Hematologic and Metabolic Health Markers in Healthy Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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