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Primary Outcomes of a Randomized Controlled Crossover Trial to Explore the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults: The Meat and Three Greens (M3G) Feasibility Trial

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Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, AL 36849, USA
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Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL 35294, USA
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Department of Food Science and Human Nutrition, Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Champaign, IL 61801, USA
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Department of Educational Foundations, Leadership, and Technology, Auburn University, Auburn, AL 36849, USA
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Department of Cell, Developmental and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL 35294, USA
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Department of Drug Discovery and Development, Auburn University Harrison School of Pharmacy, Auburn, AL 36849, USA
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Department of Pharmacy Services, Auburn University Harrison School of Pharmacy, Auburn, AL 36849, USA
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Author to whom correspondence should be addressed.
Nutrients 2019, 11(10), 2349; https://doi.org/10.3390/nu11102349
Received: 18 July 2019 / Revised: 18 September 2019 / Accepted: 23 September 2019 / Published: 2 October 2019
(This article belongs to the Special Issue Nutrition and Cancer: From Prevention to Survivorship)
Preclinical and observational research suggests green leafy vegetables (GLVs) may reduce the risk of red meat (RM)-induced colonic DNA damage and colon cancer (CC). We sought to determine the feasibility of a high GLV dietary intervention in adults with an increased risk of CC (NCT03582306) via a 12-week randomized controlled crossover trial. Participants were randomized to immediate or delayed (post-4-week washout) intervention groups. During the 4-week intervention period, participants were given frozen GLVs and counseled to consume one cooked cup equivalent daily. The primary outcomes were: accrual—recruiting 50 adults in 9 months; retention—retaining 80% of participants at completion; and adherence—meeting GLV intake goals on 90% of days. Adherence data were collected twice weekly and 24-h dietary recalls at each time point provided nutrient and food group measures. The Food Acceptability Questionnaire (FAQ) was completed to determine acceptability. On each of the four study visits, anthropometrics, stool, saliva, and blood were obtained. Fifty adults were recruited in 44 days. Participants were 48 ± 13 years of age, 62% female, and 80% Caucasian, with an average BMI at screening of 35.9 ± 5.1. Forty-eight (96%) participants were retained and completed the study. During the intervention phase, participants consumed GLVs on 88.8% of days; the adherence goal of one cup was met on 73.2% of days. Dietary recall-derived Vitamin K and GLVs significantly increased for all participants during the intervention periods. Overall satisfaction did not differ between intervention and control periods (p = 0.214). This feasibility trial achieved accrual, retention and acceptability goals, but fell slightly short of the benchmark for adherence. The analysis of biological specimens will determine the effects of GLVs on gut microbiota, oxidative DNA damage, and inflammatory cytokines. View Full-Text
Keywords: chemoprevention; colon cancer; diet; green leafy vegetables; red meat chemoprevention; colon cancer; diet; green leafy vegetables; red meat
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Frugé, A.D.; Smith, K.S.; Riviere, A.J.; Demark-Wahnefried, W.; Arthur, A.E.; Murrah, W.M.; Morrow, C.D.; Arnold, R.D.; Braxton-Lloyd, K. Primary Outcomes of a Randomized Controlled Crossover Trial to Explore the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults: The Meat and Three Greens (M3G) Feasibility Trial. Nutrients 2019, 11, 2349.

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