Effect of ASEA on Energy Expenditure and Fat Oxidation in Humans
A Randomized, Cross-Over Clinical Trial to Evaluate the Acute Effects of ASEA on Energy Expenditure and Fat Oxidation in Humans
1 other identifier
interventional
15
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Nov 2012
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 19, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedJune 24, 2013
June 1, 2013
4 months
June 19, 2013
June 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resting Energy Expenditure
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.
24-hours
Secondary Outcomes (1)
Plasma Hormones
0900 and 1100 hours
Study Arms (2)
ASEA water
ACTIVE COMPARATORSubjects 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
PLACEBO COMPARATORSubjects 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- woman
- postmenopausal
- healthy
- age 50-65
- BMI 25-35 kg/m²
- exercise less than 150 minutes per week
- weight neutral for past 6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nutrition Research Institute
Kannapolis, North Carolina, 28081, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew G Swick, PhD
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2013
First Posted
June 24, 2013
Study Start
November 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
June 24, 2013
Record last verified: 2013-06