Table 2.

Randomized controlled trials published 2013–2016 on the impact of fruit and vegetable intake and biomarkers for metabolic disease^*

Reference	Study design	Subjects	Intervention	Endpoints	Outcome
Wallace et al. (2013) (4)	Randomized, 3 arms, parallel design, isocaloric	Overweight or obese non-diabetic Irish adults at high risk of cardiovascular disease (n=89)	Dietary advice with provision of F&V: 1–2 vs. 4 vs. 7 servings of F&V per day. Duration of intervention phase: 12 weeks Intervention diets included fruit juice	Primary: insulin resistance (clamp) Secondary: fasting glucose, fasting insulin, HOMA-IR	No significant intervention effect on insulin resistance, fasting glucose, fasting insulin, HOMA-IR
Agebratt et al. (2016) (15)	Randomized, 2 arms, parallel design	Normal weight non-diabetic Swedish university students (n=30)	Supplementation of 7 kcal per kg bodyweight per d of either fruits or nuts Duration of intervention phase: 8 weeks Fruit intervention diet did not include juice	Body weight, hepatic fat content, basal metabolic rate, fasting glucose, fasting insulin, HbA1c Hierarchy of endpoints not defined.	No significant intervention effect on body weight, hepatic fat content basal metabolic rate, fasting glucose, fasting insulin, or HbA1c.
Jarvi et al. (2016) (16)	Randomized, 2 arms, parallel design	Overweight or obese non-diabetic Swedish adults (n=62)	General dietary advice plus provision of 500 g of F&V intake per day (intervention) vs. general dietary advice only (control) Duration of intervention phase: 16 weeks Intervention diets did not include juice	Body weight, fasting glucose, fasting insulin, HbA1c Hierarchy of endpoints not defined.	No significant intervention effect on body weight, fasting glucose, fasting insulin, or HbA1c.
Sahariah et al. (2016) (17)	Randomized, 2 arms, parallel design	Women aged <40 years, intending to become pregnant, and living in slums in Mumbai, India (n=1,008)	Provision of a snack to be consumed >3 times per week: fried dough filled with green leafy vegetables, fruit, and milk (treatment) vs. a low-micronutrient vegetable (control) Duration of intervention phase: ~40–45 weeks Fruit intervention diet did not include juice	Primary: GDM prevalence, as assessed by oral glucose tolerance test, at 28–32 weeks gestation Secondary: fasting glucose, 120-min glucose during oral glucose tolerance test, fasting insulin	Based on WHO 1999 criteria for diagnosis of GDM: significantly lower prevalence of GDM in intervention vs. treatment group Based on WHO 2013 criteria for diagnosis of GDM: no statistically significant difference No significant intervention effect on fasting glucose, 120-min glucose, or fasting insulin

^*Abbreviations: DEXA: dual-energy x-ray absorptiometry, F&V: fruit and vegetables, GDM: gestational diabetes mellitus, HbA1c: glycated hemoglobin, HOMA-IR: homeostasis model assessment index of insulin resistance, WHO: world health organization