Nutrient-Fortified Beverage Study

The objective of this study is to assess the effects of nutrient-fortified beverage on mental energy in healthy human subjects.

Study Overview

• Status: Completed
• Conditions: Normal Controls
• Intervention / Treatment: Other: Anti-Oxidant Drink

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is male or female, 18-70 years of age, inclusive.
2. Subject has a body mass index (BMI) ≥17.0 and ≤32.9 kg/m2 at visit 1 (day -14 to -2).
3. Subject has no health conditions that would prevent him/her from fulfilling the study requirements as judged by the Investigator on the basis of medical history, and routine laboratory test results.
4. Subject is a non-smoker, defined as no tobacco use for ≥6 months prior to visit 1 (day -14 to -2).
5. Individual is willing to maintain a habitual diet and physical activity patterns throughout the study period.
6. Subject is willing to consume study product and standardized meals.
7. Individual is willing to abstain from caffeinated beverages and other caffeine-containing products for 12 h prior to all test visits (visits 2, 3, and 4; days 0, 3, and 6).
8. Subject is willing to abstain from alcohol consumption and avoid non-routine vigorous physical activity for 24 h prior to all test visits (visits 2, 3, and 4; days 0, 3, and 6).
9. Subject is willing to discontinue any vitamin/mineral or dietary supplements use for 2 weeks prior to visit 2 (day 0) and throughout the study period.
10. Subject is a female who is willing to schedule the randomization visit (visit 2, day 0) during the luteal phase of her menstrual cycle, defined as days 15 to the end of the cycle, where day 1 is the first day of menses, where appropriate.
11. Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

1. Subject is unable to understand and/or perform required tests and questionnaires (i.e., subjects cannot complete the practice tests, or tasks).
2. Subject is color blind.
3. Subject has an abnormal laboratory test result of clinical significance, including, but not limited to creatinine ≥1.5 mg/dL and ALT or AST ≥1.5X upper limit of normal at visit 1 (day -14 to -2).
4. Subject has a known allergy or sensitivity to study products or any ingredients of the study products, standardized meals/snacks provided.
5. Subject has a gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
6. Subject has diagnosed depression, schizophrenia, or dementia in the last 2 years prior to visit 1 (day -14 to -2).
7. Subject has a history or presence of clinically important cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, and/or stroke), renal, hepatic, endocrine (including type 1 or type 2 diabetes mellitus), pulmonary, biliary, pancreatic, or neurologic disorders.
8. Subject has extreme dietary habits (e.g., vegan, Atkins diet, very high protein).
9. Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the blood pressure measured at visit 1, (day -14 to -2). One re-test will be allowed on a separate day prior to visit 2 (day 0) for subjects whose blood pressure exceeds either of these cut points at visit 1.
10. Subject has a history or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
11. Subject has signs/symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory infection). Test visits (visits 2, 3, and 4; days 0, 3, and 6) will be re-scheduled to allow subject to be symptom-free of any type of systemic infection for at least 5 d.
12. Subject has recently used antibiotics (within 5 d of any test visit; Appendix 1). Test days (visits 2, 3, and 4; days 0, 3, and 6) will be rescheduled to allow the subject to be free of antibiotic therapy for at least 5 d.
13. Subject has a history of use of psychotropic medications within 6 months of visit 2 (day 0) and throughout study period.
14. Subject has used any other prescription medications, including over-the-counter medications within 2 weeks of visit 2 (day 0; Appendix 1) and throughout study period.
15. Subject has used any over-the-counter or prescription sleep aid products (including dietary supplements) within 2 weeks of visit 2 (day 0) and throughout study period.
16. Subject has a diagnosed sleep disorder (e.g., sleep apnea) or occupation where sleep during the overnight hours is irregular (e.g., 3rd shift or overnight workers).
17. Subject consumes excessive amounts of caffeine (>4 cups of caffeinated coffee/d or >400 mg caffeine/d from caffeine-containing products).
18. Subject is a female, who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.
19. Subject has a recent history of (within 12 months of screening; visit 1, day -14 to -2) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
20. Subject has been exposed to any non-registered drug product within 30 d prior to screening.
21. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control plus low level nutrient fortification	Other: Anti-Oxidant Drink
Experimental: Control plus increasing level nutrient fortification	Other: Anti-Oxidant Drink
Placebo Comparator: Caffeine-free, carbonated soft drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is the changes in the ratings in mood, short-term recognition memory, and attention from pre- to post-study product consumption	The primary outcome is the changes in the ratings from computer administered tasks within the domains of mood, short-term recognition memory, and attention from pre- to post-study product consumption and between treatment conditions	0-2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma nutrient metabolites	0-7 hours

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Estimate): April 3, 2014
• Last Update Submitted That Met QC Criteria: March 31, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: PEP-1319