Status:
UNKNOWN
Phytochemicals on "Metabolic Aging" in Older Overweight Adults
Lead Sponsor:
Biofortis, Merieux NutriSciences
Conditions:
Mitochondrial Functions
Eligibility:
All Genders
55+ years
Phase:
NA
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 progressiv...
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...
Eligibility Criteria
Inclusion
- Generally healthy
- Age, ≥55 y old
- BMI, ≥27 and \<35 kg/m2
- Consume a typical American diet, \<3 servings of combined fruits and vegetables daily
- Waist:hip ratio \>0.8 for women and \>0.9 for men, and waist:height ratio ≥0.5
- Willing to consume study meals for 8 wk
- Do not have allergic reaction to plant foods
- Willing to take the assigned supplement for 6 wk
Exclusion
- Unusual dietary pattern, including vegan/vegetarian
- Cigarette smoking and/or nicotine replacement use in the last 6 months
- Intend to be pregnant, pregnancy, and breastfeeding
- Use of medications known to change lipid metabolism
- Steroid use, except nasal and non-prescription topical treatments
- Active treatment for cancer of any type \>1 y, except non-melanoma skin cancer
- Have an immunodeficiency condition
- Use of immunosuppressive medications within the last 6 months
- Weekly alcoholic intake \>14 drinks (168 oz beer, 56 oz wine, 14 oz hard liquor)
- Drugs known to influence fecal microbiota: Regular use of fiber supplements such as Metamucil, probiotics, prebiotics, laxatives, stool softeners, H2 blockers, proton pump inhibitors (PPI) or antacids.
- Antibiotic use within 3 months prior to or during study participation
- Colonoscopy or colonoscopy prep within 3 months prior to or during study
- Infrequent (\<3/wk) or excessive (\>3/d) number of regular bowel movements
- History of a bilateral mastectomy with nodal dissection
- Consume ≥3 servings of fruits and vegetables daily one average
- Gastrointestinal diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease or inflammatory bowel disease which will be found based on the self-report during the screening visit
- Diabetes and/or use of diabetes medications
- Unstable thyroid disease or adjustment of thyroid medication in past 6 months
- Abnormal values of standard blood biochemistries that interfere with study outcomes based on study physician's discretion
- Infection or immunization within 30 days prior to study admission
- Use anticoagulants, such as heparin, warfarin (coumadin), or Plavix in past 6 months
- On or planning to be on a weight loss regimen
- Gain or loss of ≥5% body weight in the last 6 months
- Inability to refrain from ASA/NSAID/Tylenol use x 720 prior to study blood draws
- Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) prebiotics, probiotics or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements 30 days prior to enrollment and throughout the entire study may be considered eligible
Key Trial Info
Start Date :
November 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04919876
Start Date
November 1 2016
End Date
June 30 2022
Last Update
July 23 2021
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging
Boston, Massachusetts, United States, 02111