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NCT Number: NCT01884727

Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans

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).

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition Research Institute

Kannapolis, North Carolina, 28081, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salt Water

Dietary Supplement

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.

ASEA water

Dietary Supplement

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

A Randomized, Cross-Over Clinical Trial to Evaluate the Acute Effects of ASEA on Energy Expenditure and Fat Oxidation in Humans

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 24, 2013
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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