Dietary Intervention for Visceral Adiposity

Completed · Not applicable · Has a placebo group

Conditions studied: Obesity

In brief

The purpose of this research study is to determine whether increased intake of dietary fiber during a 12-week, low-calorie weight loss intervention affects abdominal fat change and improves cardiovascular risk factors in African-American women more than a standard weight loss intervention. The investigators are testing two main hypothesis: Hypothesis 1: Women in the high dietary fiber intervention group will lose significantly more abdominal fat around their organs than women in the standard fiber group. Hypothesis 2: Women in the high dietary fiber intervention group will have lower blood pressure, fasting glucose, fasting lipids and inflammatory factors at 3-months compared to women in the control group.

Key facts

Study ID

NCT01350518

Run by

Wake Forest University Health Sciences

People needed

30

Starts

2011-02-01

Expected to finish

2014-03-01

Last updated by the study team

2018-08-28

Who can join

Age: 20 and older, up to 50. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Pre-menopausal
• Self-identified as an African-American woman
• Aged 20-50 years
• Willing and able to provide informed consent
• No contraindication to weight loss

You may not qualify if…

• Diabetes or currently taking medication to lower blood sugar
• Currently on lipid lowering medications
• Currently taking chronic steroids
• Current diagnosis of kidney or heart failure
• Untreated hypothyroidism or hyperthyroidism
• BMI < 30 kg/m2 or waist circumference < 88 cm
• Current fiber supplementation
• Current pregnancy
• Body mass > 140 kg (CT limit)
• Inability to speak or read English
• Gastrointestinal disorders that prohibit the increased consumption of fiber
• Current participation in a structured weight loss/diet intervention program
• Inability to consume artificial sweeteners
• Inability or unwillingness to travel to the CRU during operating hours at the required frequency.

Where it is running

• Wake Forest University Clinical Research Unit — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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