Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-05 @ 10:41 PM
Study NCT ID:
NCT03089151
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2017-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Denver Garden Environment and Microbiome Study Disease
Sponsor:
University of Colorado, Boulder
Organization:
Study Overview
Official Title:
A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DGEM
Brief Summary:
An interdisciplinary team with extensive garden study experience conducted a pilot randomized controlled clinical trial to see whether gardening reduced risk factors for diseases like cancer and heart disease. The pilot trial will provide preliminary data on associations between human microbiome, diet, physical activity, and social interactions and the outcomes of weight status and key inflammatory biomarkers.
Detailed Description:
The pilot study will lead to development of a future, large randomized controlled clinical trial, by fulfilling the following aims:
Pilot Aim 1: Demonstrate feasibility of recruitment and ability to perform study procedures.
Pilot Aim 2: Demonstrate the ability to measure accurately chronic disease risk factors such as diet, physical activity, weight gain, microbiome characteristics and inflammatory biomarkers.
Pilot Aim 3: Provide preliminary results on the efficacy of gardens as a preventive intervention, and estimates for a detailed power analysis for the proposed subsequent larger trial.
Aim 3a: Demonstrate that compared to non-gardeners, gardeners have 1) greater intake of fruits and vegetables; 2) better Healthy Eating Index (HEI); 3) lower Diet Inflammatory Index (DII); 4) reduced sedentary time and increased moderate-to-vigorous physical activity (MVPA); and reduced age-associated weight gain.
Aim 3b: For gardeners and non-gardeners, sample garden soil, gut, skin, and oral microbiome at six time points from April through September to characterize and compare bacterial load, pathogenic taxa, taxonomic diversity, relative dominance, indicator taxa, and metabolomic results.
Aim 3c: Demonstrate that gardening reduces inflammatory biomarkers linked to heart disease and cancer, including CRP, IL1b, IL4, IL6, IL10, and TNFa, and that the effect of gardening is mediated by diet, weight gain, physical activity and characteristics of the microbiome.
Pilot Aim 1: Demonstrate feasibility of recruitment and ability to perform study procedures.
Pilot Aim 2: Demonstrate the ability to measure accurately chronic disease risk factors such as diet, physical activity, weight gain, microbiome characteristics and inflammatory biomarkers.
Pilot Aim 3: Provide preliminary results on the efficacy of gardens as a preventive intervention, and estimates for a detailed power analysis for the proposed subsequent larger trial.
Aim 3a: Demonstrate that compared to non-gardeners, gardeners have 1) greater intake of fruits and vegetables; 2) better Healthy Eating Index (HEI); 3) lower Diet Inflammatory Index (DII); 4) reduced sedentary time and increased moderate-to-vigorous physical activity (MVPA); and reduced age-associated weight gain.
Aim 3b: For gardeners and non-gardeners, sample garden soil, gut, skin, and oral microbiome at six time points from April through September to characterize and compare bacterial load, pathogenic taxa, taxonomic diversity, relative dominance, indicator taxa, and metabolomic results.
Aim 3c: Demonstrate that gardening reduces inflammatory biomarkers linked to heart disease and cancer, including CRP, IL1b, IL4, IL6, IL10, and TNFa, and that the effect of gardening is mediated by diet, weight gain, physical activity and characteristics of the microbiome.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: