A fixed diet, 23 hours in a metabolic chamber, four weeks of medication and a six-week commitment to a study, all for a higher metabolism and a $750 compensation? Would you be willing to participate?
Sixty people were.
The Pennington Biomedical Research Center is aiding Takeda Pharmaceuticals with research on a new drug for metabolism.
Research for this drug began in December 2001, but each participant is in the study for six weeks from the day he or she begins. Participants began at different times so each will finish at different times.
Pennington has only two metabolic chambers to conduct the testing so the visits must be staggered.
The metabolic chambers measure metabolism by measuring the carbon dioxide-oxygen exchange, according to Liz Tucker, clinic coordinator in the clinical trial department at Pennington.
For this particular metabolism study, applicants needed to be overweight, male or female, younger than 45, non-smokers, non-diabetics and taking no medication.
Tucker said overweight means the company needs people of a certain body mass index or a certain body size.
Takeda set the parameters, she said.
Cale Smith, a 31-year-old participant in the study, began the study in December and finished two weeks ago.
Pennington contacted Smith by mail and asked if he was interested in participating. “When I was in college, I did a study with them,” Smith said.
The drug company contacted Pennington and asked it to test its product.
Tucker said the center usually tests the drugs when the company is trying to get FDA approval.
For three days, participants go to the center for breakfast and dinner and take a packed lunch.
Smith said for dinner he ate meals like spaghetti and meatballs with a side of vegetables, bread and milk. There were limited amounts of food served, however. Participants get a certain amount of food depending on their weights and the amount of calories they are allowed.
For breakfast, participants had a bagel one day, then toast and cereal the next day and milk or juice to drink.
Smith said the packed lunches were good and contained a lot of food. During the day, he only could drink water or caffeine-free diet drinks because other drinks contain calories.
Smith said during the initial three days, researchers do not want you to lose weight.
Tucker said Pennington controls every nutrient in their diet, such as fat, protein and caffeine.
After the three-day period, each participant must go back to Pennington for 36 hours of testing to determine the person’s weight, blood pressure and metabolism rate before Pennington administers drugs.
Pennington tests to establish these factors before any drugs are taken. The measurements are used to compare to rates measured after the participant takes the medication for four weeks.
For 23 hours, participants stay in the metabolic chamber. During the time, they can sleep, watch TV, read or do whatever else they would like to do. The chamber is designed to measure breathing to measure metabolism.
Participants spend the remaining 13 hours getting an IV, then going to breakfast, then giving blood samples.
After the tests, participants begin taking the medication. After two weeks, participants bring the empty bottle back in and get another bottle with two more weeks worth of medication.
Two weeks after finishing the study, researchers contact participants to make sure no side effects occurred from the medication.
Smith said he has experienced no side effects.
Smith said he does not know if he had results overall because of the medication. But during the holidays, while eating a lot, Smith did not notice any weight gain.
“I usually gain five to 10 pounds over the holiday,” Smith said. “I think it had something to do with it.”
Smith said he liked participating in the study and said he would encourage others to participate.
“Anything to get a new drug out there for people, I’m all for,” Smith said.