Effects of Oxandrolone on Cardiometabolic Health in Boys with Klinefelter syndrome: A Randomized Controlled Trial

Introduction: Previous evidence suggests that soy containing foods may have beneficial effects on lipid and glycemic metabolism due to their biologically active components, including soy protein and isoflavones. Pregnancy is associated with changes in glucose and lipid metabolism, partially attributable to elevated estrogen concentrations. We have previously reported a significant, inverse association between urinary excretion of isoflavones and cardiometabolic risk markers in pregnant women, using data from the National Health and Nutrition Examination Survey (NHANES). Further studies are needed to determine the cardiometabolic health effects of soy intake in pregnant women. Hypothesis: We hypothesize that consumption of soy-based whole foods is safe and acceptable for pregnant women and has beneficial cardiometabolic health effects. Methods: A pilot randomized controlled trial (RCT) was conducted in 30 pregnant women who received counseling to consume either a high-soy or low-soy foods containing diet. Assessments (physical and anthropometric measurements, food frequency questionnaires, fasting blood samples) were conducted at 14 and 28 weeks of pregnancy, and 6 weeks’ postpartum. Monthly follow-up calls were conducted by research team coordinator to assess safety and encourage adherence. Results: Both the high-soy and low-soy groups demonstrated high adherence (80-90%), defined as consuming soy foods ≥ 15 days in the past four weeks for high-soy group and ≤ 5 days for low-soy group. Five subjects in the high-soy group reported adverse events (nausea, vomiting, diarrhea, itchy mouth); all were transient and resolved without sequelae. No adverse events were reported in the low-soy group. Skinfold thickness decreased (-4.8 mm) in the high-soy group and increased (+3.6 mm) in the low-soy group (p=0.04). There was a trend towards lower BMI in the high-soy compared to low-soy group at 28 weeks (+1.4 vs. +3.6 kg/m 2 , respectively, p=0.15) and postpartum (-1.2 vs. +0.6 kg/m 2 , respectively, p=0.14). This decrease in BMI was predominantly a loss of body fat and not lean mass. There were no significant differences between groups in fasting glucose, HDL-C, LDL-C, TG, or VLDL concentrations. Conclusions: In conclusion, results from this pilot RCT support the acceptability and safety of consuming soy-based whole foods during pregnancy. A larger-scale RCT is needed to further elucidate the effects of soy-based foods on cardiometabolic risk factors during pregnancy, as well as the transgenerational effects on their offspring.

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Effect of a lifestyle intervention in obese infertile women on cardiometabolic health and quality of life: A randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0190662 ◽

2018 ◽

Vol 13 (1) ◽

pp. e0190662 ◽

Cited By ~ 19

Author(s):

Lotte van Dammen ◽

Vincent Wekker ◽

Anne M. van Oers ◽

Meike A. Q. Mutsaerts ◽

Rebecca C. Painter ◽

...

Keyword(s):

Quality Of Life ◽

Randomized Controlled Trial ◽

Lifestyle Intervention ◽

Controlled Trial ◽

Cardiometabolic Health ◽

Infertile Women ◽

Randomized Controlled

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Rationale and Protocol for a Randomized Controlled Trial Comparing Fast versus Slow Weight Loss in Postmenopausal Women with Obesity—The TEMPO Diet Trial

Healthcare ◽

10.3390/healthcare6030085 ◽

2018 ◽

Vol 6 (3) ◽

pp. 85 ◽

Cited By ~ 1

Author(s):

Radhika Seimon ◽

Alice Gibson ◽

Claudia Harper ◽

Shelley Keating ◽

Nathan Johnson ◽

...

Keyword(s):

Weight Loss ◽

Randomized Controlled Trial ◽

Body Composition ◽

Eating Disorder ◽

Controlled Trial ◽

Energy Restriction ◽

Cardiometabolic Health ◽

Meal Replacement ◽

Randomized Controlled ◽

Eating Disorder Behaviors

Very low energy diets (VLEDs), commonly achieved by replacing all food with meal replacement products and which result in fast weight loss, are the most effective dietary obesity treatment available. VLEDs are also cheaper to administer than conventional, food-based diets, which result in slow weight loss. Despite being effective and affordable, these diets are underutilized by healthcare professionals, possibly due to concerns about potential adverse effects on body composition and eating disorder behaviors. This paper describes the rationale and detailed protocol for the TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity), in a randomized controlled trial comparing the long-term (3-year) effects of fast versus slow weight loss. One hundred and one post-menopausal women aged 45–65 years with a body mass index of 30–40 kg/m2 were randomized to either: (1) 16 weeks of fast weight loss, achieved by a total meal replacement diet, followed by slow weight loss (as for the SLOW intervention) for the remaining time up until 52 weeks (“FAST” intervention), or (2) 52 weeks of slow weight loss, achieved by a conventional, food-based diet (“SLOW” intervention). Parameters of body composition, cardiometabolic health, eating disorder behaviors and psychology, and adaptive responses to energy restriction were measured throughout the 3-year trial.

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Hybrid Neuromuscular Training Improves Cardiometabolic Health and Alters Redox Status in Inactive Overweight and Obese Women: A Randomized Controlled Trial

Antioxidants ◽

10.3390/antiox10101601 ◽

2021 ◽

Vol 10 (10) ◽

pp. 1601

Author(s):

Alexios Batrakoulis ◽

Athanasios Z. Jamurtas ◽

Dimitrios Draganidis ◽

Kalliopi Georgakouli ◽

Panagiotis Tsimeas ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Redox Status ◽

Atherogenic Index ◽

Neuromuscular Training ◽

Cardiometabolic Health ◽

Obese Women ◽

Cvd Risk ◽

Randomized Controlled ◽

Hybrid Type

This randomized controlled trial investigated the effects of a 5-month high-intensity hybrid-type neuromuscular training program with nontraditional implements on cardiometabolic health, redox status, and cardiovascular disease (CVD) risk in inactive overweight and obese women. Forty-nine inactive female participants with overweight and obesity (age: 36.4 ± 4.4 years; BMI: 29.1 ± 2.9 kg/m2) were randomly assigned to either a control (C, n = 21) or a training group (TR, n = 28). TR followed a 20-week supervised, progressive, time-efficient (3 days/week; 6–15 min net exercise time) program implementing loaded fundamental movement patterns with prescribed work-to-rest time intervals (20–40 s, 1:2, 1:1, 2:1) in a circuit fashion (2–3 rounds). Cardiometabolic risk factors were measured at baseline and post-training as secondary outcomes of a larger randomized controlled trial. At post-intervention, TR demonstrated favorable changes in resting heart rate (−7%, p = 0.043), high-density lipoprotein (+18.1%, p = 0.029), atherogenic index (−17%, p = 0.045), mean arterial pressure (−4.5%, p = 0.03), waist circumference (−6.2%, p = 0.005), waist-to-hip ratio (−4.6%; p = 0.015), metabolic syndrome severity score (−222%, p = 0.024), full 30-year CVD risk (−15.8%, p = 0.002) and hard 30-year CVD risk (−17.6%, p = 0.01), vascular age (−7.8%, p = 0.002), protein carbonyls (−45.7%, p = 0.001), catalase activity (+15.2%, p = 0.023), and total antioxidant capacity (+11.4%, p = 0.002) relative to C. Additionally, TR induced beneficial changes in fasting glucose (−3.4%, p = 0.002), homeostatic model assessment for insulin resistance (−15.7%, p < 0.001), diastolic blood pressure (−5.6%, p < 0.001), reduced glutathione (+39.8%, p < 0.001), 10-year CVD risk (−17.4%, p = 0.011), and total bilirubin (−21.7%, p < 0.001) compared to baseline. These results suggest that hybrid-type neuromuscular training may improve aspects of cardiometabolic health and antioxidant status in inactive overweight and obese women providing a time-efficient (~100 min/week) exercise approach in a real-world gym setting.

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Influence of daily fresh pear consumption on biomarkers of cardiometabolic health in middle-aged/older adults with metabolic syndrome: a randomized controlled trial

Food & Function ◽

10.1039/c8fo01890a ◽

2019 ◽

Vol 10 (2) ◽

pp. 1062-1072

Author(s):

Negin Navaei ◽

Shirin Pourafshar ◽

Neda S. Akhavan ◽

Nicole S. Litwin ◽

Elizabeth M. Foley ◽

...

Keyword(s):

Older Adults ◽

Metabolic Syndrome ◽

Randomized Controlled Trial ◽

Functional Food ◽

Controlled Trial ◽

Cardiometabolic Health ◽

Middle Aged ◽

Randomized Controlled

Previous research suggests potential for fresh pears as a functional food for promoting cardiometabolic health.

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High Intensity Interval- vs Moderate Intensity- Training for Improving Cardiometabolic Health in Overweight or Obese Males: A Randomized Controlled Trial

PLoS ONE ◽

10.1371/journal.pone.0138853 ◽

2015 ◽

Vol 10 (10) ◽

pp. e0138853 ◽

Cited By ~ 79

Author(s):

Gordon Fisher ◽

Andrew W. Brown ◽

Michelle M. Bohan Brown ◽

Amy Alcorn ◽

Corey Noles ◽

...

Keyword(s):

Randomized Controlled Trial ◽

High Intensity ◽

Controlled Trial ◽

Moderate Intensity ◽

Cardiometabolic Health ◽

Randomized Controlled ◽

High Intensity Interval ◽

Intensity Training

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Comparison of High-Intensity Interval Training and Moderate-to-Vigorous Continuous Training for Cardiometabolic Health and Exercise Enjoyment in Obese Young Women: A Randomized Controlled Trial

PLoS ONE ◽

10.1371/journal.pone.0158589 ◽

2016 ◽

Vol 11 (7) ◽

pp. e0158589 ◽

Cited By ~ 54

Author(s):

Zhaowei Kong ◽

Xitao Fan ◽

Shengyan Sun ◽

Lili Song ◽

Qingde Shi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Young Women ◽

Controlled Trial ◽

Interval Training ◽

Cardiometabolic Health ◽

High Intensity Interval Training ◽

Continuous Training ◽

Randomized Controlled ◽

Exercise Enjoyment ◽

High Intensity Interval

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Effects of a High-Protein Diet Including Whole Eggs on Muscle Composition and Indices of Cardiometabolic Health and Systemic Inflammation in Older Adults with Overweight or Obesity: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu10070946 ◽

2018 ◽

Vol 10 (7) ◽

pp. 946 ◽

Cited By ~ 15

Author(s):

Christian Wright ◽

Jing Zhou ◽

R. Sayer ◽

Jung Kim ◽

Wayne Campbell

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Systemic Inflammation ◽

Controlled Trial ◽

Cardiometabolic Health ◽

Muscle Composition ◽

Randomized Controlled ◽

Age Related ◽

Over Time ◽

Overweight Or Obesity

Age-related increases in intermuscular adipose tissue (IMAT) impair muscle quality, decrease functional capacity, and promote several cardiometabolic and inflammatory disorders. Whether these age-related alterations in muscle composition improve by consuming a high-protein (HP) diet with whole eggs are unclear. This parallel-design, randomized-controlled trial assessed the effects of a 12-week eucaloric HP diet with three whole eggs per day (1.4 g protein kg−1 day−1) versus a normal-protein diet void of eggs (NP, 0.8 g protein kg−1 day−1) on muscle composition (IMAT), cardiometabolic health, and systemic inflammation in older adults with overweight or obesity (12 men and 10 women; age 70 ± 5 years, BMI 31.3 ± 3.2 kg/m2, mean ± SD). No changes in muscle composition were observed over time, independent of protein intake. Total body weight was reduced in both groups (−3.3 ± 1.2%) and lean mass was preserved only with the HP diet. LDL concentration and hip circumference decreased only with the NP diet, while MCP-1 and HsCRP concentrations increased over time in both groups. A HP diet with whole eggs promotes lean mass retention with modest weight loss, but does not positively influence muscle composition, cardiometabolic health or systemic inflammation, compared to a NP diet void of eggs.

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