Trial Outcomes & Findings for Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects (NCT NCT01145066)

NCT ID: NCT01145066

Last Updated: 2019-07-18

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

baseline

Results posted on

2019-07-18

Participant Flow

80 participants signed consent, only 71 were randomized to an arm/group

Participant milestones

Participant milestones
Measure	Borage and Echium Oil Combination borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil corn oil: contains 4.5 g/day linoleic acid
Overall Study STARTED	26	20	25
Overall Study COMPLETED	22	16	21
Overall Study NOT COMPLETED	4	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Borage and Echium Oil Combination borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil corn oil: contains 4.5 g/day linoleic acid
Overall Study To resume NSAIDs	2	2	1
Overall Study Non-related surgery	0	0	1
Overall Study Withdrawal by Subject	0	0	2
Overall Study To start new med	1	0	0
Overall Study problems swallowing capsule	1	0	0
Overall Study Abdominal discomfort	0	1	0
Overall Study Low platelet count	0	1	0

Baseline Characteristics

Botanical Oil Supplementation in Diabetic and Metabolic Syndrome Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid	Total n=59 Participants Total of all reporting groups
Age, Continuous	57.4 years STANDARD_DEVIATION 7.8 • n=93 Participants	56.2 years STANDARD_DEVIATION 8.7 • n=4 Participants	59.9 years STANDARD_DEVIATION 9.8 • n=27 Participants	57.96 years STANDARD_DEVIATION 8.8 • n=483 Participants
Sex: Female, Male Female	10 Participants n=93 Participants	10 Participants n=4 Participants	15 Participants n=27 Participants	35 Participants n=483 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	24 Participants n=483 Participants

PRIMARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Fasting Insulin	15.4 μIU/mL Standard Deviation 2.0	19.1 μIU/mL Standard Deviation 4.5	20.2 μIU/mL Standard Deviation 3.2

PRIMARY outcome

Timeframe: 4 weeks and 8 weeks combined

Fasting insulin data at 4 and 8 weeks was averaged.

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Fasting Insulin	17.7 μIU/mL Standard Deviation 2.6	24.6 μIU/mL Standard Deviation 6.8	20.6 μIU/mL Standard Deviation 3.3

PRIMARY outcome

Timeframe: baseline

Changes in high sensitive C-reactive protein (hsCRP) were assessed.

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
hsCRP	3.03 mg/L Standard Deviation .85	6.08 mg/L Standard Deviation 3.19	2.36 mg/L Standard Deviation .57

PRIMARY outcome

Timeframe: 4 weeks and 8 weeks combined

Changes in high sensitive C-reactive protein (hsCRP) were assessed and data at 4 and 8 weeks was averaged..

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
hsCRP	3.06 mg/L Standard Deviation .86	3.59 mg/L Standard Deviation 1.03	3.72 mg/L Standard Deviation 1.00

PRIMARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Leptin	33.3 ng/mL Standard Deviation 6.2	45.1 ng/mL Standard Deviation 11.0	53.5 ng/mL Standard Deviation 6.8

PRIMARY outcome

Timeframe: 4 weeks and 8 weeks combined

Data at 4 and 8 weeks was averaged.

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Leptin	33.9 ng/mL Standard Deviation 7.4	40.6 ng/mL Standard Deviation 7.2	44.2 ng/mL Standard Deviation 5.3

SECONDARY outcome

Timeframe: baseline

Outcome measures

SECONDARY outcome

Timeframe: 4 weeks and 8 weeks combined

Data at 4 and 8 weeks was averaged.

Outcome measures

SECONDARY outcome

Timeframe: baseline

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks and 8 weeks combined

Population: No data collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Fasting Glucose	125.9 mg/dL Standard Deviation 7.3	133.5 mg/dL Standard Deviation 16.7	130.0 mg/dL Standard Deviation 9.8

SECONDARY outcome

Timeframe: 4 weeks and 8 weeks combined

Data at 4 and 8 weeks was averaged.

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Fasting Glucose	125.9 mg/dL Standard Deviation 1.09	128.7 mg/dL Standard Deviation 11.1	130.7 mg/dL Standard Deviation 11.2

SECONDARY outcome

Timeframe: baseline

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Hemoglobin Levels	6.81 mg/dL Standard Deviation .30	7.42 mg/dL Standard Deviation .33	7.15 mg/dL Standard Deviation .34

SECONDARY outcome

Timeframe: 4 weeks and 8 weeks combined

Data at 4 and 8 weeks was averaged.

Outcome measures

Outcome measures
Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Hemoglobin Levels	6.90 mg/dL Standard Deviation .27	7.20 mg/dL Standard Deviation .32	7.07 mg/dL Standard Deviation .35

Adverse Events

Borage and Echium Oil Combination

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Fish Oil

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Corn Oil

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Borage and Echium Oil Combination n=26 participants at risk borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=20 participants at risk Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=25 participants at risk corn oil: contains 4.5 g/day linoleic acid
Immune system disorders Sick/virus	11.5% 3/26 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	15.0% 3/20 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	12.0% 3/25 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Gastrointestinal disorders GI Upset	0.00% 0/26 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	5.0% 1/20 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/25 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Nervous system disorders Headache	3.8% 1/26 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/20 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	0.00% 0/25 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.
Metabolism and nutrition disorders Weak	0.00% 0/26 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	5.0% 1/20 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.	4.0% 1/25 • up to 8 weeks Adverse Events were monitored/assessed without regard to the specific Adverse Event Term.

Additional Information

Dr. Michael Seeds

Wake Forest University Health Sciences

Phone: 3367169811

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Borage and Echium Oil Combination n=22 Participants borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA borage/echium oil combination: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA	Fish Oil n=16 Participants Croda 18:12 fish oil fish oil: 1.6g/day EPA and 1.08g/day DHA	Corn Oil n=21 Participants corn oil: contains 4.5 g/day linoleic acid
Serum Fatty Acids C14:1	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0
Serum Fatty Acids Cl4:0	.69 percentage of total fatty acids Standard Deviation .08	.72 percentage of total fatty acids Standard Deviation .07	.70 percentage of total fatty acids Standard Deviation .07
Serum Fatty Acids C15:0	.13 percentage of total fatty acids Standard Deviation .02	.16 percentage of total fatty acids Standard Deviation .02	.15 percentage of total fatty acids Standard Deviation .02
Serum Fatty Acids C15:1	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0
Serum Fatty Acids C16:0	20.64 percentage of total fatty acids Standard Deviation .41	21.65 percentage of total fatty acids Standard Deviation .47	21.19 percentage of total fatty acids Standard Deviation .40
Serum Fatty Acids C16:1 n-7	1.58 percentage of total fatty acids Standard Deviation .08	1.92 percentage of total fatty acids Standard Deviation .24	1.68 percentage of total fatty acids Standard Deviation .13
Serum Fatty Acids C17:1	.10 percentage of total fatty acids Standard Deviation .02	.13 percentage of total fatty acids Standard Deviation .03	.08 percentage of total fatty acids Standard Deviation .02
Serum Fatty Acids C18:0	7.23 percentage of total fatty acids Standard Deviation .14	7.00 percentage of total fatty acids Standard Deviation .25	7.47 percentage of total fatty acids Standard Deviation .09
Serum Fatty Acids C18:1	.12 percentage of total fatty acids Standard Deviation .07	.17 percentage of total fatty acids Standard Deviation .06	.21 percentage of total fatty acids Standard Deviation .06
Serum Fatty Acids C18:1 n-9	19.6 percentage of total fatty acids Standard Deviation .44	21.92 percentage of total fatty acids Standard Deviation .98	20.63 percentage of total fatty acids Standard Deviation .96
Serum Fatty Acids C18:1 n-11	1.5 percentage of total fatty acids Standard Deviation .07	1.84 percentage of total fatty acids Standard Deviation .06	1.60 percentage of total fatty acids Standard Deviation .06
Serum Fatty Acids C18:2 n-6 [LA]	32.67 percentage of total fatty acids Standard Deviation .98	29.71 percentage of total fatty acids Standard Deviation 1.28	31.99 percentage of total fatty acids Standard Deviation 1.26
Serum Fatty Acids C18:3 n-6 [GLA]	.59 percentage of total fatty acids Standard Deviation .04	.55 percentage of total fatty acids Standard Deviation .05	.53 percentage of total fatty acids Standard Deviation .03
Serum Fatty Acids C18:3 n-3 [ALA]	.80 percentage of total fatty acids Standard Deviation .05	.77 percentage of total fatty acids Standard Deviation .09	.73 percentage of total fatty acids Standard Deviation .06
Serum Fatty Acids C18:4 n-3 [SDA]	.01 percentage of total fatty acids Standard Deviation .01	.01 percentage of total fatty acids Standard Deviation .01	.03 percentage of total fatty acids Standard Deviation .02
Serum Fatty Acids C20:0	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0	.01 percentage of total fatty acids Standard Deviation .01
Serum Fatty Acids C20:1 n-9	.04 percentage of total fatty acids Standard Deviation .01	.10 percentage of total fatty acids Standard Deviation .02	.08 percentage of total fatty acids Standard Deviation .02
Serum Fatty Acids C20:2 n-6	.32 percentage of total fatty acids Standard Deviation .01	.33 percentage of total fatty acids Standard Deviation .02	.30 percentage of total fatty acids Standard Deviation .02
Serum Fatty Acids C20:3 n-6 [DGLA]	1.51 percentage of total fatty acids Standard Deviation .08	1.43 percentage of total fatty acids Standard Deviation .09	1.68 percentage of total fatty acids Standard Deviation .08
Serum Fatty Acids C20:4 n-6 [AA]	9.12 percentage of total fatty acids Standard Deviation .40	8.68 percentage of total fatty acids Standard Deviation .40	8.17 percentage of total fatty acids Standard Deviation .56
Serum Fatty Acids C20:5 n-3 [EPA]	.573 percentage of total fatty acids Standard Deviation .05	.56 percentage of total fatty acids Standard Deviation .07	.48 percentage of total fatty acids Standard Deviation .04
Serum Fatty Acids C22:0	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0
Serum Fatty Acids C22:1 n-9	.15 percentage of total fatty acids Standard Deviation .06	0 percentage of total fatty acids Standard Deviation 0	.05 percentage of total fatty acids Standard Deviation .04
Serum Fatty Acids C22:2 n-6	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0	0 percentage of total fatty acids Standard Deviation 0
Serum Fatty Acids C22:5 n-3 [DPA]	.55 percentage of total fatty acids Standard Deviation .02	.59 percentage of total fatty acids Standard Deviation .03	.54 percentage of total fatty acids Standard Deviation .03
Serum Fatty Acids C24:0	.02 percentage of total fatty acids Standard Deviation .02	0 percentage of total fatty acids Standard Deviation 0	.02 percentage of total fatty acids Standard Deviation .02
Serum Fatty Acids C22:6 n-3 [DHA]	1.63 percentage of total fatty acids Standard Deviation .10	1.73 percentage of total fatty acids Standard Deviation .016	1.71 percentage of total fatty acids Standard Deviation .12
Serum Fatty Acids C24:1 n-9	.01 percentage of total fatty acids Standard Deviation .01	.04 percentage of total fatty acids Standard Deviation .02	.03 percentage of total fatty acids Standard Deviation .02