Penn State University
University Park, Pennsylvania, 16802, United States
NCT Number: NCT02180841
The purpose of the proposed pilot study is to evaluate the effects of a soy protein isolate with naturally occurring isoflavones on the properties of HDL-C (total HDL-C, HDL particle size and HDL function), central blood pressure, and indices of arterial stiffness.
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Notify Me35 year–60 year
All sexes
Interventional
Not applicable
University Park, Pennsylvania, 16802, United States
The investigators propose to conduct a randomized three-period, crossover study to evaluate the effect of soy protein supplementation on HDL function. To ensure that there are no effects of treatment order on outcome measures, subjects will be randomized to a treatment sequence. Healthy males and females (n = 20; 35 to 60 years of age) with systolic blood pressure greater than 120 mm Hg and/or diastolic blood pressure greater than 80 mm Hg will be recruited for this study. Subjects will undergo 3 treatment periods in random order. These treatment periods will include: A) 25 g/d soy protein powder; B) 50 g/d soy protein powder; C) 0 g/d protein powder (control). Each treatment will be provided for 6 weeks separated by a 2-week break between treatment periods. All subjects will be encouraged to maintain body weight and physical activity levels during the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will consume 25g soy protein powder daily for a 6 week treatment period.
Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
Participants will consume 50g soy protein powder daily for a 6 week treatment period.
Time frame: Baseline
Prior to start of intervention
Time frame: Week 6
End of treatment 1
Time frame: Week 14
End of treatment 2
Time frame: Week 22
End of treatment 3
Time frame: Baseline
Prior to start of intervention
Time frame: Week 6
End of treatment 1
Time frame: Week 14
End of treatment 2
Time frame: Week 22
End of treatment 3
Time frame: Baseline
Prior to start of intervention
Time frame: Week 6
End of treatment 1
Time frame: Week 14
End of treatment 2
Time frame: Week 22
End of treatment 3
Time frame: Baseline
Prior to start of intervention
Time frame: Week 6
End of treatment 1
Time frame: Week 14
End of treatment 2
Time frame: Week 22
End of treatment 3
Penn State University
Other
Acronym: SOY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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