Trial Outcomes & Findings for Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion (NCT NCT03613740)

NCT ID: NCT03613740

Last Updated: 2024-11-21

Results Overview

WC was measured with a flexible tape at the midline between the highest point of the iliac crest and the lowest rib in the midaxillary line.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: 12 weeks.
• Results posted on: 2024-11-21

Participant Flow

Participant milestones

Measure	Fucoxanthin Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo Received one (1) Magnesium stearate capsule, once a day
Overall Study STARTED	14	14
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Fucoxanthin Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo Received one (1) Magnesium stearate capsule, once a day
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Baseline characteristics by cohort

Measure	Fucoxanthin n=14 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=14 Participants Received one (1) magnesium stearate capsule, once a day.	Total n=28 Participants Total of all reporting groups
Age, Continuous	49.3 years STANDARD_DEVIATION 7.8 • n=5 Participants	45.6 years STANDARD_DEVIATION 9.1 • n=7 Participants	47.4 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mexico	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants
Waist Circumference	101.2 cm STANDARD_DEVIATION 9.1 • n=5 Participants	102.1 cm STANDARD_DEVIATION 5.0 • n=7 Participants	101.7 cm STANDARD_DEVIATION 7.2 • n=5 Participants
Body Weight	80.6 kg STANDARD_DEVIATION 11.2 • n=5 Participants	80.9 kg STANDARD_DEVIATION 8.6 • n=7 Participants	80.7 kg STANDARD_DEVIATION 9.8 • n=5 Participants
Body Mass Index (BMI)	31.1 kg/m^2 STANDARD_DEVIATION 3.6 • n=5 Participants	30.7 kg/m^2 STANDARD_DEVIATION 2.3 • n=7 Participants	30.9 kg/m^2 STANDARD_DEVIATION 3.0 • n=5 Participants
Body Fat	34.6 Percentage STANDARD_DEVIATION 8.6 • n=5 Participants	34.3 Percentage STANDARD_DEVIATION 6.8 • n=7 Participants	34.4 Percentage STANDARD_DEVIATION 7.6 • n=5 Participants
Systolic Blood Pressure	126.1 mmHg STANDARD_DEVIATION 10.3 • n=5 Participants	120.8 mmHg STANDARD_DEVIATION 15.7 • n=7 Participants	124.1 mmHg STANDARD_DEVIATION 13.3 • n=5 Participants
Diastolic Blood Pressure	81.5 mmHg STANDARD_DEVIATION 6.5 • n=5 Participants	80.3 mmHg STANDARD_DEVIATION 8.8 • n=7 Participants	80.9 mmHg STANDARD_DEVIATION 7.6 • n=5 Participants
Fasting Serum Glucose	5.5 mmol/L STANDARD_DEVIATION 0.6 • n=5 Participants	5.7 mmol/L STANDARD_DEVIATION 0.5 • n=7 Participants	5.6 mmol/L STANDARD_DEVIATION 0.5 • n=5 Participants
Triglycerides	2.2 mmol/L STANDARD_DEVIATION 0.7 • n=5 Participants	2.4 mmol/L STANDARD_DEVIATION 1.0 • n=7 Participants	2.3 mmol/L STANDARD_DEVIATION 0.9 • n=5 Participants
Total Cholesterol	5.3 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants	5.0 mmol/L STANDARD_DEVIATION 0.9 • n=7 Participants	5.1 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants
High-Density Lipoprotein (HDL-C)	1.2 mmol/L STANDARD_DEVIATION 0.3 • n=5 Participants	1.2 mmol/L STANDARD_DEVIATION 0.2 • n=7 Participants	1.2 mmol/L STANDARD_DEVIATION 0.2 • n=5 Participants
Low-Density lipoprotein (LDL-C)	3.1 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants	2.67 mmol/L STANDARD_DEVIATION 0.9 • n=7 Participants	2.9 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants
Very-Low-Density Lipoprotein (VLDL)	1.0 mmol/L STANDARD_DEVIATION 0.3 • n=5 Participants	1.1 mmol/L STANDARD_DEVIATION 0.5 • n=7 Participants	1.0 mmol/L STANDARD_DEVIATION 0.5 • n=5 Participants
Matsuda-DeFronzo insulin sensitivity index	2.07 Index STANDARD_DEVIATION 0.74 • n=5 Participants	2.12 Index STANDARD_DEVIATION 1.10 • n=7 Participants	2.10 Index STANDARD_DEVIATION 0.92 • n=5 Participants
Stumvoll index	2403 Index STANDARD_DEVIATION 621 • n=5 Participants	2155 Index STANDARD_DEVIATION 698 • n=7 Participants	2279 Index STANDARD_DEVIATION 660 • n=5 Participants
Total Insulin Secretion	0.84 Ratio STANDARD_DEVIATION 0.31 • n=5 Participants	0.80 Ratio STANDARD_DEVIATION 0.21 • n=7 Participants	0.82 Ratio STANDARD_DEVIATION 0.27 • n=5 Participants
Alanine Aminotransferase	0.45 ukat/L STANDARD_DEVIATION 0.29 • n=5 Participants	0.53 ukat/L STANDARD_DEVIATION 0.32 • n=7 Participants	0.49 ukat/L STANDARD_DEVIATION 0.30 • n=5 Participants
Aspartate Aminotransferase	0.39 ukat/L STANDARD_DEVIATION 0.31 • n=5 Participants	0.40 ukat/L STANDARD_DEVIATION 0.26 • n=7 Participants	0.40 ukat/L STANDARD_DEVIATION 0.28 • n=5 Participants
Creatinin	78.4 µmol/L STANDARD_DEVIATION 23.6 • n=5 Participants	86.9 µmol/L STANDARD_DEVIATION 32.6 • n=7 Participants	82.6 µmol/L STANDARD_DEVIATION 28.3 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)

WC was measured with a flexible tape at the midline between the highest point of the iliac crest and the lowest rib in the midaxillary line.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Waist Circumference (WC)	98.9 cm Standard Deviation 9.3	102.1 cm Standard Deviation 5.6

PRIMARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Fasting serum glucose concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Fasting Serum Glucose	5.5 mmol/L Standard Deviation 0.6	5.6 mmol/L Standard Deviation 0.5

PRIMARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

TG concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Triglycerides (TG)	2.1 mmol/L Standard Deviation 0.7	2.4 mmol/L Standard Deviation 0.9

PRIMARY outcome

Timeframe: 12 weeks.

Serum HDL-C concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
High-Density Lipoprotein (HDL-C)	1.2 mmol/L Standard Deviation 0.2	1.2 mmol/L Standard Deviation 0.2

PRIMARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Blood pressure was evaluated using a digital sphygmomanometer after a resting period of 15 min with the subject sitting; the bracelet was adjusted 3.0 cm above the fold of the elbow of the left arm.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Systolic Blood Pressure	120.8 mmHg Standard Deviation 9.7	119.1 mmHg Standard Deviation 14.5

PRIMARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Blood pressure was evaluated using a digital sphygmomanometer after a resting period of 15 min with the subject sitting; the bracelet was adjusted 3.0 cm above the fold of the elbow of the left arm.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Diastolic Blood Pressure	78.6 mmHg Standard Deviation 6.3	79.2 mmHg Standard Deviation 7.4

PRIMARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

The Matsuda-DeFronzo index measures whole-body insulin sensitivity from serum insulin and glucose levels during an oral glucose tolerance test (OGTT). The index is calculated with the formula: 10,000 / sqrt([fasting glucose (mg/dL) × fasting insulin (µU/mL)] × [mean glucose × mean insulin during OGTT]). The scale ranges from 0 to infinity, with higher values indicating greater insulin sensitivity. Typical values for healthy individuals range between 2 and 10, while lower values suggest insulin resistance.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Matsuda-DeFronzo Insulin Sensitivity Index	2.19 index Standard Deviation 0.90	2.19 index Standard Deviation 1.07

PRIMARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

The Total Insulin Secretion is calculated as the ratio of the area under the curve (AUC) for insulin to the AUC for glucose during a 120-minute oral glucose tolerance test (OGTT). The formula is: AUC insulin / AUC glucose. AUC values are derived from concentrations measured at 0, 30, 60, 90, and 120 minutes post-ingestion of a glucose solution at week 12. Interpretation of the AUC insulin/AUC glucose ratio is as follows: values <0.5 indicate insulin resistance, values between 0.5 and 1.0 suggest moderate insulin secretion, and values >1.0 reflect optimal insulin secretion.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Total Insulin Secretion	1.02 Ratio Standard Deviation 0.32	0.85 Ratio Standard Deviation 0.23

PRIMARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

The Stumvoll index measures the first phase of insulin secretion, incorporates demographic data along with plasma glucose (mmol/L) and insulin (pmol/L) levels measured during an oral glucose tolerance test (OGTT). There is no universally standardized ranges, values ranges from 0 to infinity; higher values indicate a better early insulin response to glucose (first 30 minutes), reflecting more effective beta-cell function.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Stumvoll Index	2907 index Standard Deviation 732	2298 index Standard Deviation 446

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Body weight was measured at baseline a bioimpedance scale.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Body Weight	79.16 kg Standard Deviation 12.3	82.1 kg Standard Deviation 7.9

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

BMI was calculated with the Quetelet index formula.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Body Mass Index (BMI)	30.3 kg/m^2 Standard Deviation 3.7	31.0 kg/m^2 Standard Deviation 2.1

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Percentage of body fat was measured using a bioimpedance scale.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Body Fat	33.0 percentage Standard Deviation 8.3	34.9 percentage Standard Deviation 7.4

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Serum Total Cholesterol concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Total Cholesterol (TC)	5.1 mmol/L Standard Deviation 1.0	4.9 mmol/L Standard Deviation 1.0

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Serum LDL-C concentration was calculated using the Friedewald formula (LDL-C = TC - (HDL-C + [TG/5])

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Low-Density Lipoprotein (LDL-C)	3.0 mmol/L Standard Error 0.9	2.7 mmol/L Standard Error 1.0

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Serum VLDL concentration was calculated with the formula: VLDL-C = TG/5.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Very-Low-Density Lipoprotein (VLDL)	0.9 mmol/L Standard Deviation 0.3	1.1 mmol/L Standard Deviation 0.4

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Serum ALT concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Alanine Aminotransferase (ALT)	0.47 ukat/L Standard Deviation 0.24	0.50 ukat/L Standard Deviation 0.29

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Serum AST concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Aspartate Aminotransferase (AST)	0.41 ukat/L Standard Deviation 0.28	0.42 ukat/L Standard Deviation 0.26

SECONDARY outcome

Timeframe: 12 weeks.

Population: All participants, including those who dropped out before the end of the study were taken into account for statistical analysis (intention to treat)

Serum creatinin concentration was measured with enzymatic/colorimetric techniques by spectrophotometry.

Outcome measures

Measure	Fucoxanthin n=13 Participants Received one (1) 12 mg fucoxanthin capsule, once a day.	Placebo n=13 Participants Received one (1) magnesium stearate capsule, once a day.
Creatinin	83.8 µmol/L Standard Deviation 21.7	76.4 µmol/L Standard Deviation 26.4

Adverse Events

Fucoxanthin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fucoxanthin n=14 participants at risk 12 mg Fucoxanthin capsule, once a day before breakfast during 90 days. Fucoxanthin: Intervention will be administered 30 minutes before breakfast.	Placebo n=14 participants at risk Homologated magnesium sterate capsule, once a day before breakfast during 90 days. Placebo: Intervention will be administered 30 minutes before breakfast.
Gastrointestinal disorders Frequent bowel movements	28.6% 4/14 • Number of events 4 • 12 weeks. Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.	21.4% 3/14 • Number of events 3 • 12 weeks. Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Flatulence	21.4% 3/14 • Number of events 3 • 12 weeks. Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.	14.3% 2/14 • Number of events 2 • 12 weeks. Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.
Nervous system disorders Headache	14.3% 2/14 • Number of events 2 • 12 weeks. Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.	7.1% 1/14 • Number of events 1 • 12 weeks. Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.
General disorders Fatigue	0.00% 0/14 • 12 weeks. Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.	7.1% 1/14 • Number of events 1 • 12 weeks. Adverse event and serious adverse event definition does not differ from the clinicaltrials.gov definitions.

Additional Information

PhD. Karina G. Pérez Rubio

University of Guadalajara

Phone: +52 1 3310585200

Email: karina.prubio@academicos.udg.mx

Results disclosure agreements

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