CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
Supplementother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01723007
NCT01723007N/ACompleted

Modifications of Body Weight and Plasma Lipids With Diet Added of Fruits: Randomized Clinical Trial in Overweight Women

Universidade Federal do Amazonas·interventional·Posted Nov 7, 2012·Updated Nov 7, 2012

In Brief

A clinical study evaluating Supplement for Hypercholesterolemia and Overweight. Completed, enrolled 49 participants across 2 sites.

Detailed Summary

The study was designed to answer the primary question: the consumption of one apple three times daily between meals reduces serum levels of cholesterol above 240 mg/dL in overweight women? The second and important hypothesis was designed for evaluate the reduction in body weight by intakes of fruits. Therefore, the increased consumption of apples could displace the consumption of other foods and promoting satiety and input significant reduction in body weight compared to other fruit (Pear) of similar nutritional composition or food (cookies) made from oats with fiber and total calories similar to those observed in these fruits. To demonstrate the effectiveness of these supplements we used a clinical trial with three arms (apple, pear and oatmeal cookies).

Study Details

Timeline

N/ACompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2012
Enrollment StartAug 1, 1999
Primary CompletionJun 1, 2000
Study CompletionJun 1, 2001
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.7 years ago

Interventions

Supplementother

The arms were assigned to receive the supplements and followed for 10 weeks. Every two weeks, the women returned to the clinic for evaluation biochemical, haemogram, anthropometric, bioimpedance, blood pressure and dietary. Weekly, returned to receive the supplements in a sealed box. They received guidance not to disclose what food were receiving the service if he found other women who also participated in the study.