Clinical Trial of Anti-oxidant Astaxanthin in Insulin-resistant Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 10/18/2017 |
| Start Date: | July 2016 |
| End Date: | April 2018 |
| Contact: | Robert R Henry, MD |
| Email: | rrhenry@outlook.com |
| Phone: | 858-552-8585 |
A Double-blinded, Placebo-controlled, Clinical Trial of Insulin-sensitizing, Anti-inflammatory and Anti-oxidant Activities of Astaxanthin in Insulin-resistant Subjects
Astaxanthin is a natural compound, present in many foodstuffs and available as a nutritional
supplement that has been shown to have beneficial effects on many of the features of insulin
resistance/glucose intolerance, at least in animals. The goal of this project is to provide a
validation of astaxanthin effects on metabolic regulation in humans and their mechanism(s) of
action, to determine if astaxanthin could have any value as a "neutraceutical" to help
improve regulation of glucose and fat metabolism in subjects with insulin resistance/ glucose
intolerance.
supplement that has been shown to have beneficial effects on many of the features of insulin
resistance/glucose intolerance, at least in animals. The goal of this project is to provide a
validation of astaxanthin effects on metabolic regulation in humans and their mechanism(s) of
action, to determine if astaxanthin could have any value as a "neutraceutical" to help
improve regulation of glucose and fat metabolism in subjects with insulin resistance/ glucose
intolerance.
Astaxanthin is a molecule of the carotenoid class that is abundant in marine animals and
plants, with the algae Haematococcus pluvialis being a particularly rich source. Astaxanthin
is a potent anti-oxidant with a unique property of being able to insert into membranes and
lipid bilayers. Astaxanthin has also been shown to be a potent anti-inflammatory agent. As
oxidative stress and inflammation are present in individuals with insulin resistance,
astaxanthin offers promise as a potential therapeutic for this patient population.
There are a number of formulations of astaxanthin that are available for use in humans. With
regard to controlled studies in humans, astaxanthin has been given at doses as high as 40
mg/day for periods from 2 to 12 weeks. Improvements in inflammation and oxidative stress were
frequently observed. With regard to metabolic regulation, improvements have been seen in HDL
and LDL levels, while others have found no changes. Glucose and insulin levels appear to be
unaltered: This lack of effect may be due to only healthy, though in some cases overweight or
obese, subjects being studied. In none of these studies, were any abnormal safety lab values
or adverse events reported. One of the intents of the current project is to perform more
detailed metabolic characterization of astaxanthin treatment effects in research participants
with insulin resistance/glucose intolerance.
The hyperinsulinemic-euglycemic glucose clamp procedure (HEC) will be used to assess insulin
sensitivity and responsiveness by measuring glucose disposal rate (GDR). Investigators will
also perform Oral Glucose Tolerance Tests (OGTT), indirect calorimetry (IDC), and 24 hour
measurement of ambulatory blood pressure (ABPM).
plants, with the algae Haematococcus pluvialis being a particularly rich source. Astaxanthin
is a potent anti-oxidant with a unique property of being able to insert into membranes and
lipid bilayers. Astaxanthin has also been shown to be a potent anti-inflammatory agent. As
oxidative stress and inflammation are present in individuals with insulin resistance,
astaxanthin offers promise as a potential therapeutic for this patient population.
There are a number of formulations of astaxanthin that are available for use in humans. With
regard to controlled studies in humans, astaxanthin has been given at doses as high as 40
mg/day for periods from 2 to 12 weeks. Improvements in inflammation and oxidative stress were
frequently observed. With regard to metabolic regulation, improvements have been seen in HDL
and LDL levels, while others have found no changes. Glucose and insulin levels appear to be
unaltered: This lack of effect may be due to only healthy, though in some cases overweight or
obese, subjects being studied. In none of these studies, were any abnormal safety lab values
or adverse events reported. One of the intents of the current project is to perform more
detailed metabolic characterization of astaxanthin treatment effects in research participants
with insulin resistance/glucose intolerance.
The hyperinsulinemic-euglycemic glucose clamp procedure (HEC) will be used to assess insulin
sensitivity and responsiveness by measuring glucose disposal rate (GDR). Investigators will
also perform Oral Glucose Tolerance Tests (OGTT), indirect calorimetry (IDC), and 24 hour
measurement of ambulatory blood pressure (ABPM).
Inclusion Criteria:
- Age: 18-75 years (inclusive)
- Both males and females
- If female, must be post-menopausal or not capable of becoming pregnant
- Able to give informed consent to the procedures
- Dyslipidemia - [TG]>150, or [LDL]>100 or [HDL]<40 for males, <50 for females or taking
a statin or fibrate
- BMI = 25-39
- Impaired fasting glucose 95>[FG]<125 and/or elevated HbA1c (5.7-6.4%)
- Concomitant medication use stable for 30 days prior to screening visit (Acceptable
medications: anti-hypertensive if blood pressure criteria met statins or fibrates)
Exclusion Criteria:
- Type 2 diabetes
- Type 1 diabetes
- Pregnant
- Younger than 18 or older than 75 years of age.
- Clinically significant abnormalities in liver (> 3x ULN) or kidney function (eGFR <
30)
- Myocardial Infarction (MI) (within 6 months of screening)
- Stroke (within 6 months of screening)
- Blood pressure (BP) >160 mmHg Systolic and >100 mmHg Diastolic
- The following medications are exclusionary: thiazolidinediones, any steroids,
anti-depressants, weight loss, and OTC antioxidants (if taking OTC antioxidant
supplements, subjects must be willing to stop taking them immediately upon site
verifying that the subject qualifies for enrollment and for the duration of the entire
study. Some OTC antioxidants may be acceptable upon approval by the Principal
Investigator.)
- Other disease, besides type 2 diabetes, influencing carbohydrate metabolism.
We found this trial at
1
site
9452 Medical Center Drive
San Diego, California 92037
San Diego, California 92037
Phone: 858-646-2884
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