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View Clinical Trial (Medical Research Study)
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Effects of Diet Changes on Metabolism - NCT00523627-85014 (Clinical Trial 181774)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy181774.aspx
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| City: |
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Phoenix |
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State:
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AZ |
| Zip Code: |
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85014 |
| Conditions: |
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Obesity - Overnutrition |
| Purpose: |
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This study, conducted at the NIH Clinical Research Unit at the Phoenix Indian Medical
Center, will examine how the body's metabolism (energy expenditure) changes when people
overeat and when they fast and how different diets (e.g., high-protein or high-fat) affect
metabolism. The results may provide information about whether there are mechanisms that make
some people more resistant than others to gaining weight when they eat more.
Non-smoking healthy subjects between 18 and 55 years of age who weigh no more than 350
pounds may be eligible for this study. Participants undergo the following procedures:
- Pregnancy test for women of childbearing age.
- Oral glucose tolerance test. For this test, an I.V. line (needle attached to a plastic
tube) is inserted into a vein to allow several blood draws without repeated needle
sticks. After the first blood sample is drawn, the subject drinks a cola-flavored sugar
solution. Five additional blood samples are then drawn over 3 hours.
- Blood test for DNA (genetic) studies related to obesity, diabetes and related medical
problems.
- DEXA scan. This test measures body fat. The subject lies on a table while a very small
dose of X-rays is passed through the body.
- Respiratory chamber. This test measures how many calories the body burns a day and
assesses energy balance between intake and expenditure. Subjects stay in a room with
two windows, equipped with a sink, toilet, television and DVD player, desk, chair,
telephone and bed for 24 hours. The test is repeated five times during the first 18-day
admission and 3 times during the second 13-day admission. For the first two sessions,
subjects are fed a diet equal to the amount of energy their body uses. For the next 6
stays they are fed double the amount of calories their body usually uses for 5 of the
stays and fast (consume nothing but water and soda without caffeine or calories) during
1 stay. The overfeeding diets may be high or low in protein, normal in protein, or high
in fat. Blood tests are done on the day of each respiratory chamber session and a
24-hour urine sample is collected for one day while in the chamber.
- Eating behavior questionnaires.
- Psychological performance tests.
Some participants are asked to volunteer to repeat two of the chamber studies to validate
the measurements. The repeat session includes only the fasting and the overfeeding with
normal protein content.
All participants are followed at 6 months with blood tests, a DEXA scan, and urine tests
(including pregnancy test for women). At annual visits for years 1 through 7, participants
have the 6-month tests plus an oral glucose tolerance test.
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| Study summary: |
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Some people appear to be more resistant than others to gaining weight when they overeat,
though they do not increase their physical activity. This may indicate that adaptive
mechanisms exist, which lead to wasting as heat part of the excess calories taken in. Such
mechanisms exist in rodents. Human studies have provided conflicting results. A pilot study
on the relationship of the weight change over time with the changes in the amount of energy
an individual uses over 24 hours (energy expenditure, EE) with 48-h overfeeding (OF) and
fasting (F) in Pima Indian men has shown that persons with the greatest increase in EE with
OF and the smallest decrease in EE with F gained the least weight over time, indicating that
the ability to waste more calories when overfed may reduce weight gain. Other studies,
however, have not shown such relationship. In addition, it has been proposed that unbalanced
(namely low-protein) diets can help magnify these effects. The aims of this study are to
test whether (a) the changes in EE in response to 24-h OF and F predict changes in weight
over two years, and (b) low-protein and high-carbohydrate diets magnify the metabolic
response to 24-h OF compared to normal protein and high-fat diets. 50 volunteers will be
evaluated at baseline, 6 months and on a yearly basis for up to 7 years. At baseline, during
two consecutive admissions 4 weeks or less apart, subjects will undergo 8 24-h sessions in a
human respiratory chamber to measure EE while on a weight-maintaining diet, and then in
random order F, 200% OF on a normal-protein diet, 200% OF on a low-protein diet, 200% OF on
a high-carbohydrate, normal-protein diet, 200% OF on a high-carbohydrate, low-protein diet,
and 200% OF on a high-fat, normal-protein diet . Body weight and composition will also be
measured at each admission. Hormonal measurements to find determinants of adaptive changes
in EE in response to OF and F will also be performed. This study will provide significant
insights into possible mechanisms that may help people resist weight gain and obesity, as
well as their determinants. |
| Criteria: |
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- INCLUSION CRITERIA:
- Age: 18-55 years, to exclude effects of aging on energy expenditure and weight change
- Premenopausal
- Weight: greater than or equal to 350 lb (maximum weight allowed on the DXA scanning
tables by the manufacturer).
EXCLUSION CRITERIA:
History or clinical manifestation of:
- Current smoking
- Impaired glucose tolerance (IGT), type 1 and type 2 diabetes
- Endocrine disorders, such as Cushing's disease, pituitary disorders, and hypo- and
hyperthyroidism
- Pulmonary disorders, including chronic obstructive pulmonary disease, which would
limit ability to follow the protocol (investigator judgment)
- Cardiovascular diseases, including coronary heart disease, heart failure,
arrhythmias, and peripheral artery disease
- Hypertension, as diagnosed and treated by an outside physician or by sitting blood
pressure measurement, using an appropriate cuff, higher than 140/90 mmHg on two or
more occasions
- Liver disease, including cirrhosis, active hepatitis B or C, and AST or ALT greater
than or equal to 3 times normal
- Renal disease, as defined by serum creatinine concentrations greater than or equal to
1.5 mg/dl and/or proteinuria > 300 mg/day (200 microgram/min)
- Central nervous system disease, including previous history of cerebrovascular
accidents, dementia, and neurodegenerative disorders
- Cancer requiring treatment in the past five years, except for non-melanoma skin
cancers or cancers that have clearly been cured or in the opinion of the investigator
carry an excellent prognosis (e.g., Stage 1 cervical cancer).
- Infectious disease such as active tuberculosis, HIV (by self-report), chronic
coccidiomycoses or other chronic infections that might influence weight.
- Conditions not specifically mentioned above may serve as criteria for exclusion at
the discretion of the investigators
Alcohol and/or drug abuse (more than 3 drinks per day and use of drugs, such as
amphetamines, cocaine, heroin, or marijuana).
Pregnancy or lactation |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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