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Effects of Freeze-dried Grape Powder on Immune Profiles in Healthy Aging Adults

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University of Connecticut

Status

Enrolling

Conditions

Inflammation
Healthy Aging

Treatments

Other: Freeze-dried whole grape powder
Other: Control grape-free powder

Study type

Interventional

Funder types

Other

Identifiers

NCT07079982
B2024-0072/24-02-508-910

Details and patient eligibility

About

The purpose of this study is to investigate the effects of consuming grape powder on immune profiles in healthy middle- and older-aged individuals. Specifically, the investigators are interested in evaluating the potential effects of grapes in influencing markers of immune function, inflammation, and metabolism that are known to change with aging. Grapes contain several nutrients and antioxidant polyphenols such as resveratrol, quercetin, vitamin K and fiber, which are known to promote heart and immune health. However, the effects of grapes on altering immune profiles within the context of aging is not well understood. Therefore, this study will explore how daily grape consumption impacts certain markers of immunity in healthy middle- and older-aged adults.

The main study procedures include consumption of a freeze-dried grape powder and control powder (which tastes the same but has none of the grape compounds that are being studied) mixed with water as a beverage on a daily basis for 4 weeks each. The investigators will additionally ask that participants avoid eating grapes and certain other antioxidant/grape-related foods and beverages throughout the 13-week study. Participants will additionally be asked to complete surveys about their diet, physical activity, and medical history, as well as provide blood samples and body weight measures throughout the course of the study. Participation in the study is expected to last about 6.25 hours over the course of 13 weeks and will include 7 visits.

Enrollment

28 estimated patients

Sex

All

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 50-75 years old (at time of screening)
  • Body mass index (BMI) 18.5 to < 30 kg/m2
  • Willing to consume grape and control powder during study periods, and refrain from eating grapes and certain other polyphenol-rich foods and beverages during the study
  • Do not fit any exclusion criteria

Exclusion criteria

  • <50 years old and >75 years old
  • BMI <18.5 and ≥ 30 kg/m2 or body weight < 110 pounds
  • Experienced >10% weight change in the past 4 weeks
  • Elevated fasting glucose levels (fasting glucose higher than 126 mg/dL) and triglycerides greater than 500 mg/dL
  • Self-reported and/or physician-diagnosed history of diabetes mellitus, coronary heart disease, stroke, renal or liver disease, cancer, eating disorders, certain severe and/or relapsing/remitting autoimmune, inflammatory, or metabolic diseases, chronic infections, scleroderma, blood clotting disorders, intravenous drug use, or current pregnancy or lactation
  • Allergy to grapes or any ingredients in the grape or control powders
  • Implanted medical device (e.g., pacemaker) or other health condition that would prevent measurement of body composition by bioelectrical impedance
  • Currently taking lipid-lowering medications (e.g., statins, fibrates), glucose-regulating medications, anti-inflammatory medications (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids), or medications that primarily affect blood clotting (e.g., warfarin), long-term antibiotics in the last 3 months, active use of probiotics during the intervention
  • Active smoker

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

28 participants in 2 patient groups, including a placebo group

Freeze-dried whole grape powder
Experimental group
Treatment:
Other: Freeze-dried whole grape powder
Control grape-free powder
Placebo Comparator group
Treatment:
Other: Control grape-free powder

Trial contacts and locations

1

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Central trial contact

Catherine J Andersen, PhD, RDN

Data sourced from clinicaltrials.gov

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