Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533891
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2020-02-03
Brief Title:
Effects of Omega-3 Fatty Acid Supplementation and Physical Training on Metabolic Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Omega-3 Fatty Acid Supplementation and Physical Training on Metabolic Health
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Supplements expired during COVID shutdown
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXC
Brief Summary:
The degree of insulin resistance in an individual can be monitored by several means including blood concentrations of insulin triglycerides HDL-C and eventually glucose In particular the ratio of triglycerides to HDL-C reflects the severity of insulin resistances impact on liver-mediated lipoprotein transport and may be a sensitive measure of early insulin resistance when fasting glucose levels are still in the normal range compensated by higher output of insulin High triglycerides and low HDL-C indicate poor metabolic health and increased risk of fatty liver and atherosclerotic cardiovascular diseases
Two diet and lifestyle strategies that have shown therapeutic promise are 1 supplementation with omega-3 fatty acids and 2 aerobic exercise training Omega-3 fatty acids can prevent the development of insulin resistance but have not been successful in reversing established insulin resistance Importantly omega-3 fatty acids are effective for improving the ratio of triglycerides to HDL-C in blood and reducing the amount of fat in the liver Aerobic exercise has demonstrated greater success for reversing established insulin resistance but it is not known if and to what degree supplementation with omega-3 fatty acids could potentiate its therapeutic efficacy and vice versa regarding dyslipidemia Both omega-3 fatty acids and exercise lead to increased blood concentrations of beneficial oxygenated lipid compounds termed oxylipins that regulate inflammatory and metabolic processes including insulin resistance linked to the development of NAFL
In preparation for studies of people in poorer metabolic health the investigators will conduct a pilot and feasibility study of relatively inactive younger adults with low dietary intake of omega-3 fatty acids to assess whether increased aerobic physical activity combined with omega-3 supplementation leads to greater improvements in blood concentrations of triglycerides HDL-C and their ratio as well as concentrations of oxylipins in the blood The investigators will also assess whether a less studied omega-3 fatty acid called DPA may have effects above and beyond those conferred by EPA and DHA which are concentrated in prescription omega-3 fatty acid products
Two diet and lifestyle strategies that have shown therapeutic promise are 1 supplementation with omega-3 fatty acids and 2 aerobic exercise training Omega-3 fatty acids can prevent the development of insulin resistance but have not been successful in reversing established insulin resistance Importantly omega-3 fatty acids are effective for improving the ratio of triglycerides to HDL-C in blood and reducing the amount of fat in the liver Aerobic exercise has demonstrated greater success for reversing established insulin resistance but it is not known if and to what degree supplementation with omega-3 fatty acids could potentiate its therapeutic efficacy and vice versa regarding dyslipidemia Both omega-3 fatty acids and exercise lead to increased blood concentrations of beneficial oxygenated lipid compounds termed oxylipins that regulate inflammatory and metabolic processes including insulin resistance linked to the development of NAFL
In preparation for studies of people in poorer metabolic health the investigators will conduct a pilot and feasibility study of relatively inactive younger adults with low dietary intake of omega-3 fatty acids to assess whether increased aerobic physical activity combined with omega-3 supplementation leads to greater improvements in blood concentrations of triglycerides HDL-C and their ratio as well as concentrations of oxylipins in the blood The investigators will also assess whether a less studied omega-3 fatty acid called DPA may have effects above and beyond those conferred by EPA and DHA which are concentrated in prescription omega-3 fatty acid products
Detailed Description:
This is a double-blind randomized placebo-controlled clinical study The treatment phase will span a continuous 6-week period Prior to the treatment phase participants will be assigned to receive the DPA enriched n-3 supplement conventional n-3 supplement or identical placebo A computer program will be used to randomly assign participants to a treatment group
Intervention protocol and study treatments
Study capsules will be provided tri-weekly at the Food Bioactives Health Lab on the University of Arizona campus Participants may schedule pick-up times that are most suitable for their schedules A staff member will be available to meet with participants at each tri-weekly pick-up appointment
The treatments are as follows
4 gd DPA enriched n-3 concentrate 980 mg DPA 380 mg EPA 1720 mg DHA
4 gd n-3 control 980 oleic acid 380 mg EPA 1720 mg DHA
4 gd placebo control light olive oil
During the 6-week treatment phase participants will consume 4 gday of the DPA-enriched concentrate n-3 matched control or placebo control Participants will be required to avoid consuming any other food or supplements that contain n-3 FA during treatment phases They will also be asked to engage in exercise ad libitum while wearing a heart rate monitor for the 6-week period
The supplementation period will be at least 6 weeks in length However it can be extended by 3 weeks up to 9 weeks total to accommodate scheduling challenges due to illness travel etc For example should a participant be unable to come in on two separate mornings for testing after 6 weeks of supplementation they may continue the supplement and schedule testing for the following week
Screening
Potential participants will be interviewed by telephone to determine their initial eligibility If they remain eligible after the telephone screening they will be further screened at the Food Bioactives Health Lab This screening visit will consist of filling out forms informed consent medical history personal information measuring height and weight so body mass index BMI can be calculated and measuring blood pressure BP If it is determined that they are still eligible following these measurements a blood sample will be taken and a complete blood cell count health panel including liver and kidney function and a blood fat panel will be performed approximately 15 mL of blood or 1 tablespoon will be taken If the initial blood draw is unsuccessful it may need to be repeated with permission of the participant Females of child-bearing age will be given a urine pregnancy test Study investigators will review all of the screening data Participants meeting eligibility criteria will be scheduled for baseline data collection and supplementation will begin thereafter
Urine Pregnancy Testing Female participants of childbearing age will be asked to provide a urine sample for pregnancy testing at baseline If a participant is pregnant she will not be able to participate in the study
Baseline and endpoint visits 3 total
Participants will undergo additional clinical and anthropometric assessments for one day at baseline screening values will be used as the second measure and two days for endpoint visits at the end of the 6-week treatment phase The baseline visit will be scheduled within 2 weeks of the participants screening visit Participants will be required to fast overnight 12 hours with no food or drink except water and abstain from alcohol for 48 hours prior to each testing day To ensure participant eligibility a brief assessment will be administered If a participant does not meet the requirements their visit will be rescheduled Testing will be conducted at the Food Bioactives Health Lab and the procedures are described in more detail below
Blood Sampling Prior to having their blood taken participants will be asked not to consume any food or drink except water for 12 hours and to avoid alcohol for 48 hours Participants also should not engage in vigorous physical activity for 12 hours prior to having their blood taken Two blood samples will be taken at baseline and at the end of the treatment phase for a total of 3 times after eligibility screening On two separate days a blood sample will be taken from the participants arm after a 12-hour fast no food or drink except water If the initial blood draw is unsuccessful it may need to be repeated with the participants permission Approximately 60 mL 4 tablespoons of blood will be collected at baseline and at the end of each treatment phase over two days separated by at least 24 hours This will be collected as 52 mL on one day and 75 mL on the other day Throughout the entire study blood will be taken 4 times for a total amount of 130 mL 85 tablespoons including the blood taken for screening tests prior to the start of the study 15 mL or 1 tablespoon
At the end of the testing period blood will be tested for the following glucose insulin triglycerides HDL-C non-HDL-C and concentrations of inflammatory markers Red blood cell fatty acid concentrations will also be measured to assess compliance
On an additional day at the end of each testing period participants will provide a blood sample 75 mL to repeat lipid measurements which can vary day-to-day
Blood samples will be stored and analyzed after all participants have completed the study Study results will be available after study completion which may take 2 years or longer
Rockport Walking Test VO2 max will be calculated using the Rockport Walking Test The test will be conducted using the indoor track at the Rec Center Participants will be allowed to warm-up and stretch prior to starting the test and will then walk 1 mile as quickly as they are able Finishing times will be noted and heart rate will be measured for 15 seconds immediately after
Body Composition Assessment Body composition will be determined using a 4-point bioelectrical impedance analysis device Weight and waist circumference will also be measured
Ad Libitum Physical Training Participants will be asked to engage in physical training ad libitum during the 6-week study period Participants will be granted access to the Rec Center and all Rec Center group fitness classes During the first week of training participants will work with a qualified study intern to establish a physical activity baseline and initial exercise plan Participants will meet with their study intern intermittently after the first week to aid in adherence to safe practices and study procedures
Midpoint Visits Supplements will be provided every 3 weeks at the Food Bioactives and Health Lab on the University of Arizona campus Participants may schedule pick up times that work best with their schedule A study staff member will be available at each pick up visit to meet with participants to answer questions or discuss side effects
Intervention protocol and study treatments
Study capsules will be provided tri-weekly at the Food Bioactives Health Lab on the University of Arizona campus Participants may schedule pick-up times that are most suitable for their schedules A staff member will be available to meet with participants at each tri-weekly pick-up appointment
The treatments are as follows
4 gd DPA enriched n-3 concentrate 980 mg DPA 380 mg EPA 1720 mg DHA
4 gd n-3 control 980 oleic acid 380 mg EPA 1720 mg DHA
4 gd placebo control light olive oil
During the 6-week treatment phase participants will consume 4 gday of the DPA-enriched concentrate n-3 matched control or placebo control Participants will be required to avoid consuming any other food or supplements that contain n-3 FA during treatment phases They will also be asked to engage in exercise ad libitum while wearing a heart rate monitor for the 6-week period
The supplementation period will be at least 6 weeks in length However it can be extended by 3 weeks up to 9 weeks total to accommodate scheduling challenges due to illness travel etc For example should a participant be unable to come in on two separate mornings for testing after 6 weeks of supplementation they may continue the supplement and schedule testing for the following week
Screening
Potential participants will be interviewed by telephone to determine their initial eligibility If they remain eligible after the telephone screening they will be further screened at the Food Bioactives Health Lab This screening visit will consist of filling out forms informed consent medical history personal information measuring height and weight so body mass index BMI can be calculated and measuring blood pressure BP If it is determined that they are still eligible following these measurements a blood sample will be taken and a complete blood cell count health panel including liver and kidney function and a blood fat panel will be performed approximately 15 mL of blood or 1 tablespoon will be taken If the initial blood draw is unsuccessful it may need to be repeated with permission of the participant Females of child-bearing age will be given a urine pregnancy test Study investigators will review all of the screening data Participants meeting eligibility criteria will be scheduled for baseline data collection and supplementation will begin thereafter
Urine Pregnancy Testing Female participants of childbearing age will be asked to provide a urine sample for pregnancy testing at baseline If a participant is pregnant she will not be able to participate in the study
Baseline and endpoint visits 3 total
Participants will undergo additional clinical and anthropometric assessments for one day at baseline screening values will be used as the second measure and two days for endpoint visits at the end of the 6-week treatment phase The baseline visit will be scheduled within 2 weeks of the participants screening visit Participants will be required to fast overnight 12 hours with no food or drink except water and abstain from alcohol for 48 hours prior to each testing day To ensure participant eligibility a brief assessment will be administered If a participant does not meet the requirements their visit will be rescheduled Testing will be conducted at the Food Bioactives Health Lab and the procedures are described in more detail below
Blood Sampling Prior to having their blood taken participants will be asked not to consume any food or drink except water for 12 hours and to avoid alcohol for 48 hours Participants also should not engage in vigorous physical activity for 12 hours prior to having their blood taken Two blood samples will be taken at baseline and at the end of the treatment phase for a total of 3 times after eligibility screening On two separate days a blood sample will be taken from the participants arm after a 12-hour fast no food or drink except water If the initial blood draw is unsuccessful it may need to be repeated with the participants permission Approximately 60 mL 4 tablespoons of blood will be collected at baseline and at the end of each treatment phase over two days separated by at least 24 hours This will be collected as 52 mL on one day and 75 mL on the other day Throughout the entire study blood will be taken 4 times for a total amount of 130 mL 85 tablespoons including the blood taken for screening tests prior to the start of the study 15 mL or 1 tablespoon
At the end of the testing period blood will be tested for the following glucose insulin triglycerides HDL-C non-HDL-C and concentrations of inflammatory markers Red blood cell fatty acid concentrations will also be measured to assess compliance
On an additional day at the end of each testing period participants will provide a blood sample 75 mL to repeat lipid measurements which can vary day-to-day
Blood samples will be stored and analyzed after all participants have completed the study Study results will be available after study completion which may take 2 years or longer
Rockport Walking Test VO2 max will be calculated using the Rockport Walking Test The test will be conducted using the indoor track at the Rec Center Participants will be allowed to warm-up and stretch prior to starting the test and will then walk 1 mile as quickly as they are able Finishing times will be noted and heart rate will be measured for 15 seconds immediately after
Body Composition Assessment Body composition will be determined using a 4-point bioelectrical impedance analysis device Weight and waist circumference will also be measured
Ad Libitum Physical Training Participants will be asked to engage in physical training ad libitum during the 6-week study period Participants will be granted access to the Rec Center and all Rec Center group fitness classes During the first week of training participants will work with a qualified study intern to establish a physical activity baseline and initial exercise plan Participants will meet with their study intern intermittently after the first week to aid in adherence to safe practices and study procedures
Midpoint Visits Supplements will be provided every 3 weeks at the Food Bioactives and Health Lab on the University of Arizona campus Participants may schedule pick up times that work best with their schedule A study staff member will be available at each pick up visit to meet with participants to answer questions or discuss side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None