Tocotrienols for Obesity of Postmenopausal Women

Obesity Clinical Trial

— VitE-obesity  

Official title:

Actions of Dietary Tocotrienols on Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705845
• Other study ID #: LBB18-147
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 15, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2023
• Source: Texas Tech University Health Sciences Center
• Contact: Chwan-Li Shen, PhD
• Phone: 8067432815
• Email: leslie.shen[@]ttuhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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) within 3 months before intervention begins.

2. Changes to medications or supplements (i.e., steroids, statins) within 3 months of the baseline study visit that could affect lipid metabolism. • If they change any medications/supplements after the baseline visit that will affect lipid metabolism, their study participation will end.

3. Taking anticoagulants that may interact with TT.

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

Related Conditions & MeSH terms

• Obesity
• Postmenopausal Women

Intervention

Drug:
• placebo softgel
Each placebo softgel of 430 mg olive oil will contain no TT or tocopherols at detectable levels.
• DeltaGold® Tocotrienol 70%
DeltaGold® Tocotrienol 70% contains 430 mg tocotrienol (90% d-tocotrienol + 10% ?-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat mass	total and regional fat mass by DXA	24 weeks
Primary	visceral adipose tissue	VAT by BIA	24 weeks
Secondary	total cholesterol	total cholesterol in serum	24 weeks
Secondary	FASN	Fatty acid synthase mRNA expression in fat tissue	24 weeks
Secondary	Oxylipins inflammation marker	oxylipins levels in plasma and adipose tissue	24 weeks
Secondary	Gut microbiota	abundance and composition of intestinal bacteria in feces	24 weeks
Secondary	hs-CRP	high-sensitivity C-reactive protein in serum	24 weeks
Secondary	leptin	serum leptin	24 weeks
Secondary	beta-oxidation	carnitine palmitoyltransferase 1A (CPT1) mRNA expression in adipose tissue	24 weeks
Secondary	endocannabinoids inflammatory markers	endocannabinoids levels in plasma and adipose tissue	24 weeks
Secondary	HDL	high density lipoprotein in serum	24 weeks
Secondary	TG	triglycerides in serum	24 weeks