Trial Outcomes & Findings for Gastrointestinal Hormonal Regulation of Obesity (NCT NCT01146704)
NCT ID: NCT01146704
Last Updated: 2025-02-04
Results Overview
The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard diet.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.
Results posted on
2025-02-04
Participant Flow
Participant milestones
| Measure |
Standard Diet
Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.
Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass: Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.
|
High Protein Diet
High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.
Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate: High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gastrointestinal Hormonal Regulation of Obesity
Baseline characteristics by cohort
| Measure |
Standard Diet
n=16 Participants
Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.
Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass: Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.
|
High Protein Diet
n=15 Participants
High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.
Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate: High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
52.69 years
n=5 Participants
|
50.26 years
n=7 Participants
|
51.48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
BMI
|
35.49 kg/m^2
n=5 Participants
|
30.542 kg/m^2
n=7 Participants
|
33.02 kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: The primary outcome of weight loss is measured at the Baseline at Day 1, and at the end of the 12 months study period for each subject.The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard diet.
Outcome measures
| Measure |
Standard Diet
n=16 Participants
Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.
Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass: Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.
|
High Protein Diet
n=15 Participants
High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% carbohydrate.
Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate: High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.
|
|---|---|---|
|
Change in Body Weight From Baseline to 12 Months
|
1.09 lbs
Interval 0.0 to 10.0
|
1.55 lbs
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: The outcome of efficacy is measured at Day 1 Baseline and at monthly visits during the 12 month study period for each subject.High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Safety variables are measured at the time any adverse events occur, and vital signs, concomitant medications and physical examination results are measured at Baseline on Day 1 and monthly throughout the 12 month study period for each subject.High-protein diet promotes sensitivity to cholecystokinin and shifts the cecal microbiome without altering brain inflammation in diet-induced obesity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPatients enrolled with a history of NAFLD will be assessed for improvement in NAFLD Fibrosis scoring index and other imaging parameters if performed as standard clinical care.
Outcome measures
Outcome data not reported
Adverse Events
Standard Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Protein Diet
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
Dr. Joseph Pisegna
Department of Veterans Affairs, VAGLAHS
Phone: 3104783711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place