Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04919876
Status:
UNKNOWN
Last Update Posted:
2021-07-23
First Post:
2018-04-10
Brief Title:
Phytochemicals on Metabolic Aging in Older Overweight Adults
Sponsor:
Biofortis Merieux NutriSciences
Organization:
Biofortis Merieux NutriSciences
Study Overview
Official Title:
The Impact of a Phytochemical Supplement on Metabolic Aging in Older Overweight Adults Relative to Young Lean Adults
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aging is a complex and inevitable biological process that is associated with numerous chronic health conditions and the development and progression of diseases It is manifested partly by a progressive decline in fitness and an increase in death The key to healthy aging is a healthy lifestyle including eating a variety of healthy foods and frequently participating in physical activities Supplements made from widely consumed plant products have the potential for promoting healthy aging However more human data is required to substantiate this potential Thus the purpose of this study is to determine examining whether older adults taking a fruitvegetable supplement for 6 weeks will have biochemical values of stool blood and urine similar to those of younger adults The fruitvegetable supplement contains a variety of vitamins and minerals and other nutrients that have been known to be beneficial to human health and many Americans may consume inadequate amounts in their daily diet In order for us to understand how these nutrients may benefit health we are interested in determining whether they can modify biochemical values of blood that occur in the body after taking the supplement for 6 weeks We aim to have 40 older subjects and 20 younger subjects complete the trial The enrolled subjects will consume prepackaged study meals for approximately 8 weeks and provide blood samples The study meals will comprise foods most Americans eat every day The older subjects but not younger subjects will take the assigned supplement The younger subjects will consume the study meals for 2 weeks and provide one blood sample during the study
Detailed Description:
Advanced age is associated with reduced mitochondrial capacity and altered metabolomic signatures relative to those at younger ages We hypothesize that supplemental fruit and vegetable phytochemicals will slow or reverse signs of metabolic aging by enhancing mitochondrial capacity in older overweightobese adults as well as shift their metabolomic signature toward those of younger leaner adults To test this hypothesis we will pursue the following specific aims in a controlled feeding trial to diminish the confounding effect of concurrent and confounding dietary factors
Specific Aim 1 To determine the extent to which supplemental fruit and vegetable concentrates will shift the mitochondrial capacity of peripheral blood mononuclear cells in older overweight older adults toward that of young lean adults
Specific Aim 2 To determine the extent to which supplemental fruit and vegetable concentrates will shift the plasma metabolomic signature of older overweight adults toward that of young lean adults
The experimental design is a randomized double-blind placebo-controlled parallel design controlled feeding trial This trial will enroll 40 older adults as well as 20 younger adults to serve as a reference to complete the study They will be generally healthy The older adults will be 55 y and have BMI 270 and 35 kgm2 and the younger adults will be 18-30 y and have BMI 185 and 27 kgm2 The older subjects will be randomized to receive either placebo PLA or fruitvegetable supplement FVS for 6 weeks after a 2-wk run-in period The younger adults serving as the reference group for the older subjects will only participate in the run-in period and will not receive any dietary supplements During the whole study including the run-in period all subjects will consume provided meals The total duration of the trial will be 10 weeks for the older subjects including screening 2-wk run-in and 6 wk of intervention as well as 4 weeks for the younger subjects including screening and 2-wk run-in In addition to consuming the provided meals for 6 weeks the older volunteers will take an assigned supplement daily Blood samples of the older volunteers will be collected at the end of the run-in and the end of the 6-wk intervention These same samples will only be collected from the younger volunteers at the end of the run-in period
Older subjects will be randomly assigned to receive one of the supplements PLA vs FVS after their eligibility is confirmed A randomization scheme will be prepared by a biostatistician using a standardized computer program for two treatment groups using a parallel design
The study supplements will be generously provided by Juice PLUS Collierville TN A matching placebo product will be manufactured by the Juice PLUS under the FDA GMP guidelines The main ingredient of the placebo will be microcrystalline cellulose-containing 05 magnesium stearate The Juice PLUS products that will be used in this intervention have been marketed in the US Microcrystalline cellulose and magnesium stearate have a GRAS status under FDA Code of Federal Regulations CFR title 21 FVS in a capsule form will be the combination of Juice Plus Garden Blend Juice Plus Orchard Blend and Juice Plus Berry Blend All Juice Plus supplements contain a fine granular powder mainly from botanical ingredients This powder is encapsulated in a size 00 gelatin capsule These three formulas will be blended to produce a uniform brown powder and packaged into study opaque capsules
Juice Plus Garden Blend consists of vegetable juice powder and pulp from carrot parsley beet kale broccoli cabbage spinach oat rice and tomato gelatin glucomannan calcium ascorbate mixed tocopherols calcium carbonate garlic powder Spirulina Pacifica natural mixed carotenoids natural enzyme blend Lactobacillus acidophilus folic acid The powder looks pale green in color and smells like cabbage Juice Plus Orchard Blend consists of fruit juice powder and pulp from apple orange pineapple cranberry peach acerola cherry beet prune date and papaya gelatin calcium ascorbate citrus pectin citrus bioflavonoids glucomannan natural mixed carotenoids natural enzyme blend bromelain papain mixed tocopherols Lactobacillus acidophilus folic acid The powder looks pink in color and smells like applecranberry Juice Plus Berry Blend consists of fruit juice and pulp powder of Concord grape blueberry cranberry blackberry bilberry raspberry black currant elderberry cocoa powder pomegranate powder green tea ginger root grape seed and artichoke leaf powder gelatin mixed tocopherols calcium ascorbate natural enzyme blend silicon dioxide vegetable-derived magnesium stearate citrus bioflavonoids from tangerine folic acid The powder looks purple in color and smells faintly of berry and cocoa
During the trial older subjects will be required to attend 1 screening visit and 3 study visits over 10 weeks and younger subjects will be required to attend 1 screening visit and 2 study visits over 4 weeks An initial screening visit Visit 1 is employed to obtain informed consent and determine each subjects eligibility A blood sample will be collected only if the subject is fasting 12 hours At Visit 2 subjects will begin to consume the provided meals for 2 weeks during the run-in period At Visit 3 all subjects will be asked to arrive at the study site after fasting for 12 h blood will be collected For younger subjects the study will complete at end of Visit 3 Older subjects will be randomly assigned to one of 2 supplements starting on the next day of Visit 3 for 6 weeks They will be instructed to take 3 capsules each with breakfast and dinner At Visit 4 final visit older subjects will be asked to arrive at the study site after fasting for 12 h blood will be collected for analyses
Younger and older subjects will consume provided meals for 2 and 8 weeks The study meals will be designed to be comparable to a diet that most average Americans are consuming Subjects may consume the study meals longer than 2 or 8 weeks because of a visit scheduling conflict or other unexpected events
Specific Aim 1 To determine the extent to which supplemental fruit and vegetable concentrates will shift the mitochondrial capacity of peripheral blood mononuclear cells in older overweight older adults toward that of young lean adults
Specific Aim 2 To determine the extent to which supplemental fruit and vegetable concentrates will shift the plasma metabolomic signature of older overweight adults toward that of young lean adults
The experimental design is a randomized double-blind placebo-controlled parallel design controlled feeding trial This trial will enroll 40 older adults as well as 20 younger adults to serve as a reference to complete the study They will be generally healthy The older adults will be 55 y and have BMI 270 and 35 kgm2 and the younger adults will be 18-30 y and have BMI 185 and 27 kgm2 The older subjects will be randomized to receive either placebo PLA or fruitvegetable supplement FVS for 6 weeks after a 2-wk run-in period The younger adults serving as the reference group for the older subjects will only participate in the run-in period and will not receive any dietary supplements During the whole study including the run-in period all subjects will consume provided meals The total duration of the trial will be 10 weeks for the older subjects including screening 2-wk run-in and 6 wk of intervention as well as 4 weeks for the younger subjects including screening and 2-wk run-in In addition to consuming the provided meals for 6 weeks the older volunteers will take an assigned supplement daily Blood samples of the older volunteers will be collected at the end of the run-in and the end of the 6-wk intervention These same samples will only be collected from the younger volunteers at the end of the run-in period
Older subjects will be randomly assigned to receive one of the supplements PLA vs FVS after their eligibility is confirmed A randomization scheme will be prepared by a biostatistician using a standardized computer program for two treatment groups using a parallel design
The study supplements will be generously provided by Juice PLUS Collierville TN A matching placebo product will be manufactured by the Juice PLUS under the FDA GMP guidelines The main ingredient of the placebo will be microcrystalline cellulose-containing 05 magnesium stearate The Juice PLUS products that will be used in this intervention have been marketed in the US Microcrystalline cellulose and magnesium stearate have a GRAS status under FDA Code of Federal Regulations CFR title 21 FVS in a capsule form will be the combination of Juice Plus Garden Blend Juice Plus Orchard Blend and Juice Plus Berry Blend All Juice Plus supplements contain a fine granular powder mainly from botanical ingredients This powder is encapsulated in a size 00 gelatin capsule These three formulas will be blended to produce a uniform brown powder and packaged into study opaque capsules
Juice Plus Garden Blend consists of vegetable juice powder and pulp from carrot parsley beet kale broccoli cabbage spinach oat rice and tomato gelatin glucomannan calcium ascorbate mixed tocopherols calcium carbonate garlic powder Spirulina Pacifica natural mixed carotenoids natural enzyme blend Lactobacillus acidophilus folic acid The powder looks pale green in color and smells like cabbage Juice Plus Orchard Blend consists of fruit juice powder and pulp from apple orange pineapple cranberry peach acerola cherry beet prune date and papaya gelatin calcium ascorbate citrus pectin citrus bioflavonoids glucomannan natural mixed carotenoids natural enzyme blend bromelain papain mixed tocopherols Lactobacillus acidophilus folic acid The powder looks pink in color and smells like applecranberry Juice Plus Berry Blend consists of fruit juice and pulp powder of Concord grape blueberry cranberry blackberry bilberry raspberry black currant elderberry cocoa powder pomegranate powder green tea ginger root grape seed and artichoke leaf powder gelatin mixed tocopherols calcium ascorbate natural enzyme blend silicon dioxide vegetable-derived magnesium stearate citrus bioflavonoids from tangerine folic acid The powder looks purple in color and smells faintly of berry and cocoa
During the trial older subjects will be required to attend 1 screening visit and 3 study visits over 10 weeks and younger subjects will be required to attend 1 screening visit and 2 study visits over 4 weeks An initial screening visit Visit 1 is employed to obtain informed consent and determine each subjects eligibility A blood sample will be collected only if the subject is fasting 12 hours At Visit 2 subjects will begin to consume the provided meals for 2 weeks during the run-in period At Visit 3 all subjects will be asked to arrive at the study site after fasting for 12 h blood will be collected For younger subjects the study will complete at end of Visit 3 Older subjects will be randomly assigned to one of 2 supplements starting on the next day of Visit 3 for 6 weeks They will be instructed to take 3 capsules each with breakfast and dinner At Visit 4 final visit older subjects will be asked to arrive at the study site after fasting for 12 h blood will be collected for analyses
Younger and older subjects will consume provided meals for 2 and 8 weeks The study meals will be designed to be comparable to a diet that most average Americans are consuming Subjects may consume the study meals longer than 2 or 8 weeks because of a visit scheduling conflict or other unexpected events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None