Denver Garden Environment and Microbiome Study Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Healthy Studies, Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/8/2017 |
| Start Date: | June 2, 2016 |
| End Date: | December 30, 2017 |
A Pilot Randomized Controlled Trial of Gardening as an Intervention to Reduce Risk of Cancer and Heart
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.
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.
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.
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.
Inclusion Criteria:
- Able to give informed consent in English or Spanish
- Aged 18 or over
- Currently on the wait list for a new garden
- Not have gardened in the past 2 gardening seasons
Exclusion Criteria:
- Is not able to complete the study requirements in Spanish or English
- Aged 17 or younger
- Has gardened in the past 2 gardening seasons
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University of Colorado, Boulder As the flagship university of the state of Colorado, CU-Boulder is...
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