Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Dietary Supplement: ASEA water; Dietary Supplement: Salt Water

• Registration Number: NCT01884727
• Lead Sponsor: University of North Carolina, Chapel Hill

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).

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 Timeline

• Study Start: 2012-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-06
• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-19
• Last Update Submitted: 2013-06-19
• Study First Posted: 2013-06-24
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ASEA water	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.
Salt water	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.

Primary Outcome Measures

Name	Time	Method
Resting Energy Expenditure	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

Name	Time	Method
Plasma Hormones	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).

Trial Locations

Locations (1)

Nutrition Research Institute; 🇺🇸 Kannapolis, North Carolina, United States