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Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans

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ClinicalTrials.gov Identifier: NCT01884727
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
To test the effect of ASEA consumption on 24-hour resting energy expenditure. Hypothesis: consumption of 8-oz of ASEA water (4-oz before breakfast and 4-oz before bedtime) will significantly elevate 24-h resting energy expenditure as compared to consumption of a placebo control (salt water, same dietary intake).

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Salt Water Dietary Supplement: ASEA water Not Applicable

Detailed Description:

The ASEA beverage is a special oral formulation produced from a pure saline solution containing 123 mg sodium and 129 mg chloride per 4 oz. serving. A proprietary electrolytic and catalytic process rearranges the salt water solution to mimic the redox signaling molecular composition of the native salt-water compounds found in and around human cells. Data obtained thus far, suggests the possibility that consumption of the ASEA beverage may increase energy expenditure and thus be beneficial for the treatment of obesity, however, this has not been assessed in human clinical studies. To this end, we will measure the effects of ASEA consumption on energy expenditure by indirect calorimetry using the indirect room calorimeter at the University of North Carolina (UNC) Nutrition Research Institute.

The primary outcome measures will be the change in 24-h energy expenditure and respiratory quotient in response to ASEA consumption. The secondary outcome variables will include changes in relevant peptide hormones, and norepinephrine/epinephrine and their relationship to changes in energy expenditure in response to consumption of ASEA.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Cross-Over Clinical Trial to Evaluate the Acute Effects of ASEA on Energy Expenditure and Fat Oxidation in Humans
Study Start Date : November 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ASEA water
Subjects to consume 4-ounces of ASEA water at 9:00 am before breakfast and 4-ounces of ASEA water at 10:15 pm prior to bedtime. 24-h resting energy expenditure and RQ to be measured.
 Dietary Supplement: ASEA water
Subjects to arrive fasted and will spend two 24-h periods inside the metabolic chamber (ASEA or salt water) with a one week interval between visits. Blood will be drawn at 9 am prior to consumption of ASEA water or breakfast, and at 11 am after consumption of ASEA water and breakfast. Subjects will receive a second portion of ASEA water at 10:15 pm just prior to bedtime. The energy content of meals will be identical at each visit.
Placebo Comparator: Salt water
Subjects to consume 4-ounces of salt water at 9:00 am before breakfast and 4-ounces of salt water at 10:15 pm prior to bedtime. 24-h resting energy expenditure and RQ to be measured.
 Dietary Supplement: Salt Water
Subjects to arrive fasted and will spend two 24-h periods inside the metabolic chamber (ASEA or salt water) with a one week interval between visits. Blood will be drawn at 9 am prior to consumption of salt water or breakfast, and at 11 am after consumption of salt water and breakfast. Subjects will receive a second portion of salt water at 10:15 pm just prior to bedtime. The energy content of meals will be identical at each visit.


Outcome Measures
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Primary Outcome Measures :
  1. Resting Energy Expenditure [ Time Frame: 24-hours ]
    Changes in 24-h resting energy expenditure and respiratory quotient (RQ) in response to ASEA or control salt water to be measured by indirect calorimetry in the room indirect calorimeter at the UNC Nutrition Research Institute.


Secondary Outcome Measures :
  1. Plasma Hormones [ Time Frame: 0900 and 1100 hours ]
    Relevant peptide hormones and nor-epinephrine/epinephrine will be assessed before consumption of ASEA (or control water) before breakfast (9:00 am) and after consumption of ASEA (or control water) after breakfast (11:00 am).


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • woman
  • postmenopausal
  • healthy
  • age 50-65
  • BMI 25-35 kg/m²
  • exercise less than 150 minutes per week
  • weight neutral for past 6 months

Exclusion Criteria:

  • smoker
  • exercises more than 150 minutes per week
  • abuses drugs or alcohol
  • vegetarian
  • taking herbal supplements, attention deficit hyperactivity disorder (ADHD) medication or thyroid medication
  • taking beta-blockers, steroidal anti-inflammatory medication
  • taking pseudoephedrine
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884727


Locations
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United States, North Carolina
Nutrition Research Institute
Kannapolis, North Carolina, United States, 28081
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Andrew G Swick, PhD University of North Carolina, Chapel Hill
More Information
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01884727    
Other Study ID Numbers: 12-1675
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013
Keywords provided by University of North Carolina, Chapel Hill:
Obesity
Overweight
Over nutrition
 nutrition disorders
energy expenditure
metabolic rate
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight