Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
NCT Number: NCT03705845
Postmenopausal women are at a risk of excessive weight gain, bone loss, hypertension, and metabolic syndrome. Obesity-induced chronic low-grade inflammation is initiated by excess nutrients in metabolic cells. Recent studies have indicated tocotrienols (one kind of vitamin E, a potent antioxidant) supplement may be good for mitigating negative impacts of obesity in postmenopausal women. The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women. The investigators will enroll 60 qualified women at the start of the study and randomly assigned to no tocotrienols (placebo) or tocotrienols group for 24 weeks. Obesity-associated measurements will be recorded using blood, urine, adipose tissue, and fecal samples. All data will be analyzed statistically.
This study is active but is not currently recruiting participants.
Notify MeFemale
Interventional
Phase 1 / Phase 2
Lubbock, Texas, 79430, United States
Postmenopausal women are at a risk of excessive weight gain, bone loss, hypertension, and metabolic syndrome. Among these risk factors, obesity is now recognized as a worldwide epidemic disease. Obesity-induced chronic low-grade inflammation is initiated by excess nutrients in metabolic cells. Aging and decline of estrogen are factors that contribute to weight gain in postmenopausal women, and approaches, such as anti-inflammatory potential in dietary antioxidants to reduce inflammation may likely combat obesity. Recent studies have indicated tocotrienols (one kind of vitamin E, a potent antioxidant) supplement may be good for mitigating negative impacts of obesity in postmenopausal women. However, no study has ever been done the role of tocotrienols in obesity-associated outcome measures in postmenopausal women. The long-term goal is to develop a new strategy featuring a dietary supplement (i.e., tocotrienols) for mitigating obesity in postmenopausal women. The purpose of the study is to examine the effect of 24-week tocotrienols on obesity-associated outcome measurements in postmenopausal women. The investigators plan to recruit postmenopausal women using flyers, non-solicited e-mail system, campus announcement, local radio, newspapers, and TV scripts. The investigators plan to enroll approximately 150-200 women to obtain 60 qualified women at the start of the study. After screening, qualified participants will be matched by body weight and age, and then randomly assigned to no tocotrienols or tocotrienols group. The outcome measures will be assessed at baseline, after 12, and after 24 weeks. Obesity-associated measurements will be recorded using blood, urine, adipose tissue, and fecal samples. The investigators will monitor safety of subjects after 12 and after 24 weeks. Food intake and physical activity will be assessed at baseline, after 12, and after 24 weeks. All data will be analyzed statistically.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each placebo softgel of 430 mg olive oil will contain no TT or tocopherols at detectable levels.
Other names: olive oil
DeltaGold® Tocotrienol 70% contains 430 mg tocotrienol (90% δ-tocotrienol + 10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.
Other names: tocotrienols
Time frame: 24 weeks
total and regional fat mass by DXA
Time frame: 24 weeks
VAT by BIA
Time frame: 24 weeks
total cholesterol in serum
Time frame: 24 weeks
Fatty acid synthase mRNA expression in fat tissue
Time frame: 24 weeks
oxylipins levels in plasma and adipose tissue
Time frame: 24 weeks
abundance and composition of intestinal bacteria in feces
Time frame: 24 weeks
high-sensitivity C-reactive protein in serum
Time frame: 24 weeks
serum leptin
Time frame: 24 weeks
carnitine palmitoyltransferase 1A (CPT1) mRNA expression in adipose tissue
Time frame: 24 weeks
endocannabinoids levels in plasma and adipose tissue
Time frame: 24 weeks
high density lipoprotein in serum
Time frame: 24 weeks
triglycerides in serum
Texas Tech University Health Sciences Center
Other
Actions of Dietary Tocotrienols on Obesity
Acronym: VitE-obesity
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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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