Trial Outcomes & Findings for Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans (NCT NCT01858376)

NCT ID: NCT01858376

Last Updated: 2018-07-27

Results Overview

Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: Baseline and 14 weeks
• Results posted on: 2018-07-27

Participant Flow

Participant milestones

Measure	Capros Dietary Supplement Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure

Capros Dietary Supplement Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.

Overall Study Dropped d/t lab work not fitting criter

4

Baseline Characteristics

Effect Of Capros Supplementation On Cardiovascular Disease Risk Factors In Humans

Baseline characteristics by cohort

Measure	Capros Dietary Supplement n=24 Participants Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	34.5 years STANDARD_DEVIATION 11.53 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants
BMI (Body Mass Index)	28.57 kg/m^2 STANDARD_DEVIATION 2.71 • n=5 Participants
Blood Pressure Systolic	116.87 mm Hg STANDARD_DEVIATION 7.19 • n=5 Participants
Height	171 cm STANDARD_DEVIATION 9.38 • n=5 Participants
Weight	185.19 lbs. STANDARD_DEVIATION 27.67 • n=5 Participants
Blood Pressure Diastolic	76.91 mm Hg STANDARD_DEVIATION 6.92 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 14 weeks

Population: number of participants analyzed is different from the participant flow module due to subjects who self reported non-compliance from pill count of the supplements and their data was not able to be used for this outcome measure.

Blood lipid panel including HDL, LDL, total cholesterol. Looking at Baseline to 12 weeks on supplement with a two week washout period

Outcome measures

Measure	Capros Dietary Supplement n=9 Participants Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.
Change From Baseline in Lipid Profile HDL cholesterol	4.20 mg/dl Interval -6.21 to 14.62
Change From Baseline in Lipid Profile LDL cholesterol	3.37 mg/dl Interval -7.62 to 14.36
Change From Baseline in Lipid Profile Total Cholesterol	-0.06 mg/dl Interval -0.34 to 0.22

SECONDARY outcome

Timeframe: Baseline and 14 weeks

High-Sensitivity C-reactive Protein analysis in blood. Looking at Baseline to 12 weeks on supplement with a two week washout period

Outcome measures

Measure

Capros Dietary Supplement n=15 Participants Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.

Changes in High-Sensitivity C-reactive Protein

0.07 mg/dl Interval -0.44 to 0.58

SECONDARY outcome

Timeframe: Baseline and 14 weeks

C-reactive protein in blood as measured in a standard hospital laboratory. 12 weeks on supplementation data presented.

Outcome measures

Measure

Capros Dietary Supplement n=15 Participants Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.

C-reactive Protein

1.61 mg/L Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline and 14 weeks

Adenosine Diphosphate (ADP), Arachidonic acid (AA), and Collagen (unsure about the specific type of collagen) agonists will be measured using optical platelet aggregometry. Looking at Baseline to 12 weeks on supplement with a two week washout period

Outcome measures

Measure	Capros Dietary Supplement n=12 Participants Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study. Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.
Changes From Baseline in Platelet Aggregometry ADP	3.34 maximum % aggregation Interval -12.56 to 19.23
Changes From Baseline in Platelet Aggregometry AA	-9.56 maximum % aggregation Interval -32.15 to 13.03
Changes From Baseline in Platelet Aggregometry Collagen	15.76 maximum % aggregation Interval -6.86 to 38.37

Adverse Events

Capros Dietary Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chandan K. Sen

The Ohio State University

Phone: 6142477786

Email: chandan.sen@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place