Trial Outcomes & Findings for Effect of a CCK-1R Agonist on Food Intake in Humans (NCT NCT00600743)
NCT ID: NCT00600743
Last Updated: 2017-04-28
Results Overview
Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
25-30 min after taking drug
Results posted on
2017-04-28
Participant Flow
Recruitment at St. Luke's Hospital from 2/22/08 through 2/19/09
Subject had to rate test food greater than 6 on a 9 point scale of liking and have BMI between 19 and 27
Participant milestones
| Measure |
1 MG CCK AGONIST NORMAL EATING
Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
|
2 MG CCK AGONIST NORMAL EATING
Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
|
4 MG CCK AGONIST NORMAL EATING
Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
|
4 MG CCK AGONIST BINGE EATING
Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
8
|
7
|
|
Overall Study
COMPLETED
|
4
|
4
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of a CCK-1R Agonist on Food Intake in Humans
Baseline characteristics by cohort
| Measure |
1 MG CCK AGONIST NORMAL EATING
n=4 Participants
Healthy/normal control participants were given both the 1 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
|
2 MG CCK AGONIST NORMAL EATING
n=4 Participants
Healthy/normal control participants were given both the 2 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
|
4 MG CCK AGONIST NORMAL EATING
n=8 Participants
Healthy/normal control participants were given both the 4mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to eat until they felt normally full.
|
4 MG CCK AGONIST BINGE EATING
n=7 Participants
Healthy/normal control participants were given both the 4 mg oral cholecystokinin (CCK) agonist (GSKI181771X) and placebo interventions at separate times in a 2 way crossover study design. After ingesting the CCK agonist or placebo, they were instructed to binge eat as much as they could.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 10.96 • n=5 Participants
|
26.25 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
23.75 years
STANDARD_DEVIATION 10.77 • n=5 Participants
|
24.00 years
STANDARD_DEVIATION 11.64 • n=4 Participants
|
24.65 years
STANDARD_DEVIATION 3.94 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
7 participants
n=4 Participants
|
23 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 25-30 min after taking drugPopulation: Subjects had to complete all trials of the protocol successfully
Food Intake at 25-30 min after having drug or placebo under normal and binge eating instructions
Outcome measures
| Measure |
Normal_1mg Drug
n=4 Participants
Eat normally 1 mg dose drug
|
Binge_4mg Drug
n=7 Participants
Non-bulimic controls Instruction to binge eat (7 subjects) drug
|
Normal_2mg Drug
n=4 Participants
Eat normally 2 mg dose drug
|
Normal_4mg Drug
n=8 Participants
Eat normally 4 mg dose drug
|
Binge - 4mg Placebo
n=7 Participants
Non-bulimic controls instruction to binge eat - placebo
|
Normal 1 mg Dose Placebo
n=4 Participants
Eat normally 1 mg dose placebo
|
Normal_2 mg Dose Placebo
n=4 Participants
Eat normally 2 mg dose placebo
|
Normal_4 mg Dose Placebo
n=8 Participants
Eat normally 4 mg dose placebo
|
|---|---|---|---|---|---|---|---|---|
|
Food Intake for 4 mg Dose of CCK Agonist vs Placebo Meal Conditions
|
447.7 grams
Standard Error 38.64
|
385.69 grams
Standard Error 29.35
|
489.63 grams
Standard Error 45.54
|
293.79 grams
Standard Error 65.58
|
532.87 grams
Standard Error 53.4
|
468.73 grams
Standard Error 74
|
442.43 grams
Standard Error 61.79
|
421.98 grams
Standard Error 69.26
|
SECONDARY outcome
Timeframe: 25-30 min after taking drugrating of "How full do you feel" by marking the feeling on a 150 mm line anchored at one end from 0 (not at all) to 150 (most imaginable).
Outcome measures
| Measure |
Normal_1mg Drug
n=4 Participants
Eat normally 1 mg dose drug
|
Binge_4mg Drug
n=7 Participants
Non-bulimic controls Instruction to binge eat (7 subjects) drug
|
Normal_2mg Drug
n=4 Participants
Eat normally 2 mg dose drug
|
Normal_4mg Drug
n=8 Participants
Eat normally 4 mg dose drug
|
Binge - 4mg Placebo
n=7 Participants
Non-bulimic controls instruction to binge eat - placebo
|
Normal 1 mg Dose Placebo
n=4 Participants
Eat normally 1 mg dose placebo
|
Normal_2 mg Dose Placebo
n=4 Participants
Eat normally 2 mg dose placebo
|
Normal_4 mg Dose Placebo
n=8 Participants
Eat normally 4 mg dose placebo
|
|---|---|---|---|---|---|---|---|---|
|
Fullness Rating
|
101 mm
Standard Error 9.74
|
144.14 mm
Standard Error 1.82
|
128.75 mm
Standard Error 9.84
|
103.13 mm
Standard Error 17.22
|
117.57 mm
Standard Error 14.64
|
79.75 mm
Standard Error 24.29
|
131.25 mm
Standard Error 9.15
|
126 mm
Standard Error 5.2
|
SECONDARY outcome
Timeframe: 25-30 min after drug or placeboResponse to question "How sick do you feel" measured on a 150 mm line anchored by none at all (0 mm left end) and extremely (150 mm right end)
Outcome measures
| Measure |
Normal_1mg Drug
n=4 Participants
Eat normally 1 mg dose drug
|
Binge_4mg Drug
n=7 Participants
Non-bulimic controls Instruction to binge eat (7 subjects) drug
|
Normal_2mg Drug
n=4 Participants
Eat normally 2 mg dose drug
|
Normal_4mg Drug
n=8 Participants
Eat normally 4 mg dose drug
|
Binge - 4mg Placebo
n=7 Participants
Non-bulimic controls instruction to binge eat - placebo
|
Normal 1 mg Dose Placebo
n=4 Participants
Eat normally 1 mg dose placebo
|
Normal_2 mg Dose Placebo
n=4 Participants
Eat normally 2 mg dose placebo
|
Normal_4 mg Dose Placebo
n=8 Participants
Eat normally 4 mg dose placebo
|
|---|---|---|---|---|---|---|---|---|
|
Sickness Report
|
21 mm
Standard Error 14.58
|
94.57 mm
Standard Error 22.48
|
10 mm
Standard Error 7.07
|
17.5 mm
Standard Error 9.64
|
61.14 mm
Standard Error 20.79
|
3 mm
Standard Error 1.35
|
10 mm
Standard Error 8.72
|
17.25 mm
Standard Error 8.43
|
Adverse Events
Normal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The provider of the drug (not sponsor - since this was an investigator initiated protocol) needs to review the results before release. In this case there was a public presentation at a scientific meeting, and the abstract was published. However, before a full report can be released, the provider of the drug needs to review the report.
- Publication restrictions are in place
Restriction type: OTHER