Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01884727|
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : June 24, 2013
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: Salt Water Dietary Supplement: ASEA water||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
- 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.
- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||50 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- age 50-65
- BMI 25-35 kg/m²
- exercise less than 150 minutes per week
- weight neutral for past 6 months
- exercises more than 150 minutes per week
- abuses drugs or alcohol
- taking herbal supplements, attention deficit hyperactivity disorder (ADHD) medication or thyroid medication
- taking beta-blockers, steroidal anti-inflammatory medication
- taking pseudoephedrine
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
|United States, North Carolina|
|Nutrition Research Institute|
|Kannapolis, North Carolina, United States, 28081|
|Principal Investigator:||Andrew G Swick, PhD||University of North Carolina, Chapel Hill|
|Responsible Party:||University of North Carolina, Chapel Hill|
|Other Study ID Numbers:||
|First Posted:||June 24, 2013 Key Record Dates|
|Last Update Posted:||June 24, 2013|
|Last Verified:||June 2013|