Recruiting

Phytochemicals

Sponsor:

Biofortis, Merieux NutriSciences

Code:

NCT04919876

Conditions

Mitochondrial Functions

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Interventions

fruit/vegetable supplement (FVS)

Placebo

Study Details

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 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.

Conditions

Mitochondrial Functions

Study ID

NCT04919876

Start date

Nov 1, 2016

Status verified date

Jul, 2021

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Feb 28, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Generally healthy
2. Age, ≥55 y old
3. BMI, ≥27 and <35 kg/m2
4. Consume a typical American diet, <3 servings of combined fruits and vegetables daily
5. Waist:hip ratio >0.8 for women and >0.9 for men, and waist:height ratio ≥0.5
6. Willing to consume study meals for 8 wk
7. Do not have allergic reaction to plant foods
8. Willing to take the assigned supplement for 6 wk

Exclusion Criteria:

1. Unusual dietary pattern, including vegan/vegetarian
2. Cigarette smoking and/or nicotine replacement use in the last 6 months
3. Intend to be pregnant, pregnancy, and breastfeeding
4. Use of medications known to change lipid metabolism
5. Steroid use, except nasal and non-prescription topical treatments
6. Active treatment for cancer of any type >1 y, except non-melanoma skin cancer
7. Have an immunodeficiency condition
8. Use of immunosuppressive medications within the last 6 months
9. Weekly alcoholic intake >14 drinks (168 oz beer, 56 oz wine, 14 oz hard liquor)
10. 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.
11. Antibiotic use within 3 months prior to or during study participation
12. Colonoscopy or colonoscopy prep within 3 months prior to or during study
13. Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
14. History of a bilateral mastectomy with nodal dissection
15. Consume ≥3 servings of fruits and vegetables daily one average
16. 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
17. Diabetes and/or use of diabetes medications
18. Unstable thyroid disease or adjustment of thyroid medication in past 6 months
19. Abnormal values of standard blood biochemistries that interfere with study outcomes based on study physician's discretion
20. Infection or immunization within 30 days prior to study admission
21. Use anticoagulants, such as heparin, warfarin (coumadin), or Plavix in past 6 months
22. On or planning to be on a weight loss regimen
23. Gain or loss of ≥5% body weight in the last 6 months
24. Inability to refrain from ASA/NSAID/Tylenol use x 720 prior to study blood draws
25. 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: fruit/vegetable supplement (FVS)

The experimental product will be prepared by combing Juice Plus+ Garden Blend, Juice Plus+ Orchard Blend, and Juice Plus+ Berry Blend in an equal proportion.

placebo comparator: placebo

The placebo comprises microcrystalline cellulose and 0.5% magnesium stearate.

Interventions

fruit/vegetable supplement (FVS)

The supplement contains polyphenols, carotenoids, and other phytochemicals present in plant foods.

Placebo

The product does not contain nutrients present in the FVS.

Primary outcome measure

  • mitochondrial function [ Time Frame: at end of 6-week intervention ]

Central Contacts and Locations

Central contacts

Locations

Jean Mayer USDA Human Nutrition Research Center on Aging

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

More Information

Sponsor

Biofortis, Merieux NutriSciences

Last update posted

Jul 23, 2021

Last verified

Jul, 2021

Keywords

  • phytochemicals, fruit, vegetables, older adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Biofortis, Merieux NutriSciences on 2021-07-23.