Trial Outcomes & Findings for Modulation of the Intestinal Microbiome by a High Protein Diet (NCT NCT04812964)
NCT ID: NCT04812964
Last Updated: 2024-08-07
Results Overview
The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard protein diet.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
Primary outcome of weight loss is measured by subtracting the baseline weight on Day 1 from the weight at the end of the 16 week study period for each subject, and converting to % of baseline weight.
Results posted on
2024-08-07
Participant Flow
106 individuals were consented but only 87 completed the first study visit and were considered to have started the study.
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
|
40
|
47
|
|
Overall Study
COMPLETED
|
31
|
27
|
|
Overall Study
NOT COMPLETED
|
9
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Modulation of the Intestinal Microbiome by a High Protein Diet
Baseline characteristics by cohort
| Measure |
Standard Diet
n=40 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=47 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=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Primary outcome of weight loss is measured by subtracting the baseline weight on Day 1 from the weight at the end of the 16 week study period for each subject, and converting to % of baseline weight.The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard protein diet.
Outcome measures
| Measure |
Standard Diet
n=31 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=27 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.
|
|---|---|---|
|
Weight Loss (% Change) in Response to Dietary Intervention Change
|
-3.83 percentage weight change from baseline
Standard Error 0.75
|
-3.89 percentage weight change from baseline
Standard Error 0.74
|
SECONDARY outcome
Timeframe: Changes in liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject.Association of change in fat mass on a high protein diet versus standard protein diet will be measured by Fibroscan (CAP score).
Outcome measures
| Measure |
Standard Diet
n=31 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=27 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 Steatosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention
|
-18.3 dB/m
Standard Error 13.3
|
3.5 dB/m
Standard Error 22.1
|
SECONDARY outcome
Timeframe: Changes in liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject.Association of change in hepatic fibrosis on a high protein diet versus standard protein diet will be measured by Fibroscan elastography.
Outcome measures
| Measure |
Standard Diet
n=31 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=27 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 Liver Fibrosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention
|
-1.77 kPa
Standard Error 0.71
|
-0.07 kPa
Standard Error 0.57
|
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. Jonathan Jacobs
VA Greater Los Angeles Healthcare System
Phone: 310-478-3711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place