Acute Effects on Stem Cell Surveillance

Natural Immune Systems

Status: Not yet enrolling

Conditions: Stem Cell Surveillance

Treatments: Dietary Supplement: Anthocyanin-rich flower/leaf extract; Dietary Supplement: Anthocyanin-rich berry extract; Dietary Supplement: Placebo; Dietary Supplement: Berry /leaf blend

Study type: Interventional

Funder types: Other

Identifiers

NCT07341178

211-002

Details and patient eligibility

About

The goal for this clinical trial is to compare acute immune effects of three nutraceutical ingredients and blends to a placebo.

Full description

The goal for this clinical trial is to compare acute immune effects of anthocyanin-rich botanical extracts and blends to a placebo.

Stem cell mobilization and homing will be evaluated through monitoring of changes to the numbers of various types of stem cells in the blood circulation.

The testing will show whether consuming the active test products lead to changes in stem cell numbers in circulation above the normal circadian changes for each participant. The normal circadian changes are documented on the clinic visit where placebo is consumed. Several different stem cell populations will be evaluated using flow cytometry.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults;

• Age 18-75 years (inclusive);

• Veins easy to see in one or both arms (to allow for the multiple blood draws);

• Willing to comply with study procedures, including:

  • Maintaining a consistent diet and lifestyle routine throughout the study,
  • Consistent habit of bland breakfasts on days of clinic visits,
  • Abstaining from exercising and nutritional supplements on the morning of a study visit,
  • Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit,
  • Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.

Exclusion criteria

• Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
• Taking anti-inflammatory medications on a daily basis;
• Currently experiencing intense stressful events/ life changes;
• Currently in intensive athletic training (such as marathon runners);
• Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication;
• An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
• Unwilling to maintain a constant intake of supplements over the duration of the study;
• Anxiety about having blood drawn;
• Pregnant, nursing, or trying to become pregnant;
• Known food allergies related to ingredients in active test product or placebo.

Prescription medication will be evaluated on a case-by-case basis.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

48 participants in 4 patient groups

Crossover Group 1, randomized

Experimental group

Description:

Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: A, B, C, D.

Treatment:

Dietary Supplement: Berry /leaf blend

Dietary Supplement: Placebo

Dietary Supplement: Anthocyanin-rich berry extract

Dietary Supplement: Anthocyanin-rich flower/leaf extract

Crossover Group 2, randomized

Experimental group

Description:

Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: B, C, D, A.

Treatment:

Dietary Supplement: Berry /leaf blend

Dietary Supplement: Placebo

Dietary Supplement: Anthocyanin-rich berry extract

Dietary Supplement: Anthocyanin-rich flower/leaf extract

Crossover Group 3, randomized

Experimental group

Description:

Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: C, D. A, B.

Treatment:

Dietary Supplement: Berry /leaf blend

Dietary Supplement: Placebo

Dietary Supplement: Anthocyanin-rich berry extract

Dietary Supplement: Anthocyanin-rich flower/leaf extract

Crossover Group 4, randomized

Experimental group

Description:

Participants consume a test product on each of the four clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 3 active test products versus placebo over 5 weeks, in this order: D, A, B, C.

Treatment:

Dietary Supplement: Berry /leaf blend

Dietary Supplement: Placebo

Dietary Supplement: Anthocyanin-rich berry extract

Dietary Supplement: Anthocyanin-rich flower/leaf extract