Tocotrienols for Obesity of Postmenopausal Women



Status:Not yet recruiting
Conditions:Obesity Weight Loss, Postmenopausal Syndrome, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:Any
Updated:1/10/2019
Start Date:March 15, 2019
End Date:September 30, 2022
Contact:Chwan-Li Shen, PhD
Email:leslie.shen@ttuhsc.edu
Phone:8067432815

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Actions of Dietary Tocotrienols on Obesity

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.

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.

Inclusion Criteria:

1. PMW with BMI ≥30 kg/m2.

2. Normal liver, kidney, and thyroid function (TSH)-sent to Quest Diagnostic Laboratory.

3. Sedentary using International Physical Activity Questionnaire (IPAQ-short form).

Exclusion Criteria:

1. Unstable body weight (more than 5% change in body weight) during the past 3 months.

2. Taking medications (i.e., steroid) or supplements that could affect lipid metabolism
or attempt for weight loss during the past 3 months.

3. Taking supplements (i.e., fish oil) that have anti-inflammatory action during the past
3 months.

4. Taking anticoagulants that may interact with TT.

5. Serious chronic disease (e.g., unstable CVD, uncontrolled diabetes and hypertension,
and active cancer).
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