Phytochemicals on "Metabolic Aging" in Older Overweight Adults

NCT04919876 | Unknown

• 1 other identifier: 2920
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

phytochemicals, fruit, vegetables, older adults

Outcome Measures

Primary Outcomes (1)

• mitochondrial function

  Targeted central carbon metabolomic in peripheral blood mononuclear cells

  at end of 6-week intervention

Secondary Outcomes (1)

• metabolomics

  at end of 6-week intervention

Other Outcomes (1)

• phytochemical concentrations in plasma

  at end of 6-week intervention

Study Arms (2)

fruit/vegetable supplement (FVS)

EXPERIMENTAL

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.

Dietary Supplement: fruit/vegetable supplement (FVS)

placebo

PLACEBO COMPARATOR

The placebo comprises microcrystalline cellulose and 0.5% magnesium stearate.

Dietary Supplement: Placebo

Interventions

fruit/vegetable supplement (FVS) DIETARY_SUPPLEMENT

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

fruit/vegetable supplement (FVS)

Placebo DIETARY_SUPPLEMENT

The product does not contain nutrients present in the FVS.

placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Biofortis, Merieux NutriSciences: lead

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

RECRUITING

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Oliver Chen, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Chen, PhD

CONTACT

6175563128; oliver.chen@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: capsules for 2 supplement have the same color and shape
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nutrition Science and Biostatistics

Model Details: randomized, double blind, placebo-controlled, parallel design, controlled feeding trial

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: June 9, 2021
• Study Start: November 1, 2016
• Primary Completion: February 28, 2022
• Study Completion: June 30, 2022
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)