Phytochemicals on "Metabolic Aging" in Older Overweight Adults

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Mitochondrial Functions

In brief

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 fruit/vegetable supplement for 6 weeks will have biochemical values of stool, blood, and urine similar to those of younger adults. The fruit/vegetable 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.

Key facts

Study ID

NCT04919876

Run by

Biofortis, Merieux NutriSciences

People needed

60

Starts

2016-11-01

Expected to finish

2022-06-30

Last updated by the study team

2021-07-23

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jean Mayer USDA Human Nutrition Research Center on Aging — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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