Studies
| Study First Submitted Date | 2019-03-25 |
| Study First Posted Date | 2019-04-23 |
| Last Update Posted Date | 2023-06-22 |
| Start Month Year | June 2024 |
| Primary Completion Month Year | June 2025 |
| Verification Month Year | June 2023 |
| Verification Date | 2023-06-30 |
| Last Update Posted Date | 2023-06-22 |
Facilities
| Sequence: | 200842267 |
| Name | Moffit Cancer Center |
| City | Tampa |
| State | Florida |
| Zip | 33612 |
| Country | United States |
Facility Contacts
| Sequence: | 28233221 |
| Facility Id | 200842267 |
| Contact Type | primary |
| Name | Tiffany Carson, PhD |
| Tiffany.Carson@moffitt.org | |
| Phone | 813-745-4944 |
Facility Investigators
| Sequence: | 18411620 |
| Facility Id | 200842267 |
| Role | Principal Investigator |
| Name | Tiffany Carson, PhD |
Conditions
| Sequence: | 52393136 |
| Name | Obesity |
| Downcase Name | obesity |
Id Information
| Sequence: | 40316466 |
| Id Source | org_study_id |
| Id Value | IRB-300003207 |
Countries
| Sequence: | 42739576 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55839984 | Sequence: | 55839985 |
| Group Type | Experimental | Group Type | Active Comparator |
| Title | DASH diet | Title | standard American diet |
| Description | calorie-restricted DASH diet (25% fat; 57% carbohydrate; 18% protein; 34 g fiber | Description | calorie-restricted standard American diet (35% fat; 51% carbohydrate; %15 protein; 14 g fiber |
Interventions
| Sequence: | 52702912 | Sequence: | 52702913 |
| Intervention Type | Behavioral | Intervention Type | Behavioral |
| Name | DASH diet | Name | standard American diet |
| Description | brief description | Description | describe |
Design Outcomes
| Sequence: | 178200566 | Sequence: | 178200567 | Sequence: | 178200568 | Sequence: | 178200569 | Sequence: | 178200570 | Sequence: | 178200571 | Sequence: | 178200572 | Sequence: | 178200573 | Sequence: | 178200574 | Sequence: | 178200575 | Sequence: | 178200576 | Sequence: | 178200577 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Mean Weight Change of Participants | Measure | Mean Weight Change of Participants | Measure | Mean Weight Change of Participants | Measure | Diet-specific changes in secondary bile acid | Measure | Diet-specific changes in secondary bile acid | Measure | Diet-specific changes in secondary bile acid | Measure | Diet-specific changes in inflammatory marker | Measure | Diet-specific changes in inflammatory marker | Measure | Diet-specific changes in inflammatory marker | Measure | Diet-specific changes in short chain fatty acids | Measure | Diet-specific changes in short chain fatty acids | Measure | Diet-specific changes in short chain fatty acids |
| Time Frame | Baseline to day 28 | Time Frame | Day 28 to Day 42 | Time Frame | Baseline to day 42 | Time Frame | Baseline to day 28 | Time Frame | day 28 to day 42 | Time Frame | baseline to day 42 | Time Frame | baseline to day 28 | Time Frame | day 28 to day 42 | Time Frame | baseline to day 42 | Time Frame | baseline to day 28 | Time Frame | day 28 to day 42 | Time Frame | baseline to day 42 |
| Description | Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged. | Description | Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged. | Description | Weight change as measured by a scale in kilograms at multiple time points will be calculated and averaged. | Description | The investigators will calculate changes in cholic acid in milligrams. | Description | The investigators will calculate changes in cholic acid in milligrams. | Description | The investigators will calculate changes in cholic acid in milligrams. | Description | The investigators will calculate changes in c-reactive protein in mg/L. | Description | The investigators will calculate changes in c-reactive protein in mg/L. | Description | The investigators will calculate changes in c-reactive protein in mg/L. | Description | The investigators will calculate changes in acetic acid in mmol/L | Description | The investigators will calculate changes in acetic acid in mmol/L | Description | The investigators will calculate changes in acetic acid in mmol/L |
Browse Conditions
| Sequence: | 194329834 | Sequence: | 194329835 | Sequence: | 194329836 | Sequence: | 194329837 | Sequence: | 194329838 |
| Mesh Term | Obesity | Mesh Term | Overweight | Mesh Term | Overnutrition | Mesh Term | Nutrition Disorders | Mesh Term | Body Weight |
| Downcase Mesh Term | obesity | Downcase Mesh Term | overweight | Downcase Mesh Term | overnutrition | Downcase Mesh Term | nutrition disorders | Downcase Mesh Term | body weight |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48525872 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | H. Lee Moffitt Cancer Center and Research Institute |
Overall Officials
| Sequence: | 29401548 |
| Role | Principal Investigator |
| Name | Tiffany L Carson, PhD |
| Affiliation | Moffitt Cancer Center |
Central Contacts
| Sequence: | 12066212 |
| Contact Type | primary |
| Name | Tiffany L Carson, PhD |
| Phone | 813-745-4944 |
| Tiffany.Carson@moffitt.org | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68450967 | Sequence: | 68450968 |
| Design Group Id | 55839984 | Design Group Id | 55839985 |
| Intervention Id | 52702912 | Intervention Id | 52702913 |
Eligibilities
| Sequence: | 30893483 |
| Gender | Female |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria:
female Exclusion Criteria: gastrointestinal (GI) conditions i.e., irritable bowel, diverticulitis, peptic ulcers, Crohn's, GI cancers, and adenatomous polyps |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254137173 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2019 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 12 |
Designs
| Sequence: | 30639226 |
| Allocation | Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 29005837 |
| Responsible Party Type | Sponsor |