Evaluation of Plant-based Nutritional Products on Stem Cells

Natural Immune Systems

Status: Unknown

Conditions: Stem Cell Homing; Stem Cell Mobilization; Hematopoietic Stem Cell Mobilization

Treatments: Other: Berry extract blend; Other: Placebo; Other: Berry Extract II; Other: Berry extract I

Study type: Interventional

Funder types: Other

Identifiers

NCT03388073

NIS135002

Details and patient eligibility

About

The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design.

Full description

The purpose of this clinical study is to evaluate acute effects of plant-based nutritional extracts on adult stem cells, using a randomized double-blinded placebo-controlled cross-over study design. The research involves testing of acute effects of single doses of antioxidant-rich berry-based extracts, compared to a placebo. Blood samples are taken at baseline and 1 and 2 hours after consuming a single dose. The blood will be used to measure the numbers of different types of stem cells, to evaluate potential effects of stem cell mobilization and homing after consuming plant-based extracts. Adult stem cells are a type of cells that play a role in repairing and rejuvenating various tissue and organs in the body. At NIS Labs, we have shown that many types of plant-based nutritional products have small but reproducible and significant effects on stem cells, cytokines, and regenerative growth factors.

Enrollment: 24 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adults 20-75 years of age;
• Body weight higher than 110 pounds;
• BMI below 35;

Exclusion criteria

• Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem);
• Currently taking daily OTC medications, such as NSAIDs, Tylenol, allergy medications, and others (birth control and 81 mg aspirin not a problem);
• Taking medications that affect the mind (such as anti-depressants) or nervous system (such as gabapentin);
• Currently experiencing intense stressful events and life changes;
• Actively depressed;
• Experiencing sleep disturbances;
• Working night shift;
• Pregnant, nursing, or trying to become pregnant;
• Food intolerances or allergies currently causing discomfort (such as Celiac's disease), due to ongoing inflammatory reactions that may negatively affect product absorption within the 3 hours of testing;
• Food allergies related to ingredients in test product.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

Berry extract I

Experimental group

Description:

Plant-based antioxidant-rich berry-based extract.

Treatment:

Other: Berry extract I

Berry extract II

Experimental group

Description:

Plant-based antioxidant-rich berry-based extract.

Treatment:

Other: Berry Extract II

Berry extract blend

Experimental group

Description:

Blend of plant-based antioxidant-rich berry-based extracts.

Treatment:

Other: Berry extract blend

Placebo

Placebo Comparator group

Treatment:

Other: Placebo