Pilot Study Evaluating the Acceptability and Absorption of the Bioactive Compounds of a Russian Tarragon Nutrasorb Bar
Condition: Diabetes Prevention
Study type: Observational

Summary: 
      The purpose of this study is to make a bar from the soy-protein Russian Tarragon complex
      (PMI-5011/Nutrasorb) that is safe and acceptable for consumption, and to test the blood
      levels of plasma bioactive (DMC-2) after ingestion of the bar. The PMI-5011/Nutrasorb comes
      from a plant source called Artemisia dracunculus. This plant has a long history of medicinal
      (health) and culinary (food) use and has been reported as effective as a traditional
      treatment for diabetes in various parts of the world.
    

Detailed description: 
      Phase 1

      Test Day: Fasting Visit (nothing to eat or drink other than water beginning at 10 pm the
      night before the test day); visit will be approximately 1 ½ hours.

      The following procedures will be done on the Test Day:

        -  Informed consent will be signed by those agreeing to participate.

        -  Body weight and height will be measured (body mass index will be calculated from these
           measures).

        -  Participants will provide a list of any medications they are currently taking.

        -  Blood pressure and pulse will be measured.

        -  Taste test of the study bar will be conducted.

        -  Participants will answer questions regarding the appearance, smell, taste, texture,
           aftertaste, and pleasantness of the bar.

      Phase 1 participants may be asked to return up to two additional times to complete the taste
      test and questions again. This will occur if the product is found unacceptable and will be
      completed after a new bar is produced.

      Phase 2

      Screening Visit: Fasting Visit (nothing to eat or drink other than water after 10 pm the
      night before the Screening Visit); visit will be approximately 1 ½ hours.

      The following procedures will be done on the Screening Visit:

        -  Informed consent will be signed by those agreeing to participate.

        -  Body weight and height will be measured (body mass index will be calculated from these
           measures).

        -  Blood pressure and pulse will be measured.

        -  Medical history questionnaire will be completed.

        -  Blood will be drawn (approximately 2 teaspoons) to assess overall health.

      Test Day: Fasting visit (nothing to eat or drink other than water after 10 pm the night
      before the Test Day); visit will be approximately 4 hours and will be completed within 30
      days after Screening Visit.

      The following procedures will be done on the Test Day:

        -  Blood will be drawn from an IV line placed in the participant's arm to assess the level
           of nutrients, blood sugar levels, and insulin levels from the study bar 10 minutes
           before the bar is consumed, immediately after the bar is consumed, and 30, 60, 120, and
           180 minutes after the bar is consumed. A total of approximately 6 teaspoons of blood
           will be drawn for this Test Day.

        -  Participants will answer questions regarding the appearance, smell, taste, texture,
           aftertaste, and pleasantness of the bar.

        -  Participants will be asked about any side effects and how they feel throughout the Test
           Day.
    

Intervention name(s): Nutrasorb bar
Intervention type(s): Dietary Supplement
Intervention description(s): 250 kcal bar containing 30 g of 5011-Nutrasorb (120 kcal), 20 g fat (100 kcal), and 30 kcal from carbohydrate and flavorings
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy males and females aged 18-50 with a body mass index between 20-30 kg/m2
      
Keywords: tarragon