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NCT Number: NCT07079982

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutritional Sciences

Storrs, Connecticut, 06269, United States

Location status: Recruiting

Location contact

Catherine J Andersen, PhD, RDN

CONTACT

[email protected]

860-486-1704

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freeze-dried whole grape powder

Other

Studying the effects of freeze-dried whole grape powder on immune profiles in healthy aging adults

Control grape-free powder

Other

Studying effects of a control grape-free powder on immune profiles in healthy aging

Primary outcomes

  1. Concentration of lipopolysaccharide (LPS)-induced interleukin-1 beta (IL-1beta) secreted from subject-derived primary immune cells ex vivo

    Time frame: 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine J Andersen, PhD, RDN

CONTACT

[email protected]

860-486-1704

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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