Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans

Sponsor

University of North Carolina, Chapel Hill (Other)

Overall Status

Completed

CT.gov ID

NCT01884727

Collaborator

(none)

Enrollment

Location

Arms

3.9

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

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 :

Nov 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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.

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

Primary Outcome Measures

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

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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