Weight Loss Associated With the Consumption of Apple
Condition: Hypercholesterolemia; Overweight
MeSH terms: Overweight; Hypercholesterolemia
Study type: Interventional

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).
    

Detailed description: 
      The basic proposal of this research was to study the effect of apple consumption as dietary
      treatment of plasma lipids and weight loss. To assess the effect of apple adding in diet,
      first was necessary to standardize the total number of meals, since the serum cholesterol
      level is influenced by this variation. Thus, in the run-in period of the study the
      researchers stabilized the number of meals. The participants increased the number of meals
      with introduction of three supplements daily.

      A possible physiological basis for the hypothesis of a protective effect of apples on serum
      cholesterol and body weight would be their fiber composition, so the study presents a
      comparison arm for the consumption of dietary fiber adjusted for total calories (oatmeal
      cookies). However, another possible physiological factor could be the energy density of
      foods. Energy density is an important determinant of energy consumption because a high intake
      of a diet low energy-dense food, such as fruits, makes excessive energy consumption more
      difficult, and few studies have been conducted on satiety and weight control and serum
      cholesterol. Recently (2012) discovered the presence on the apple peel a substance named
      ursolic acid that showed the effect in reducing body weight.

      Previous studies have observed a reduction in cholesterol levels associated with consumption
      of apple and for to test this hypothesis, as well as weight reduction, a randomized clinical
      trial study with three arms where the apple was compared with an equal amount of fiber and
      total calories by eating oatmeal cookies and other fruit (pear).

      We postulated that, if a group receive an other fruit could be excluding the possibility of
      the effect being attributed to the increased consumption of fruits displacing other foods and
      not apple effect. The pear was chosen due to its percentage of the nutritional components
      similar the apple. Before beginning the survey raised the consumption of apple in Brazil to
      assess the feasibility of such a study, if we confirmed the hypothesis of a protective
      effect. The apple consumption in Brazil increased in recent years. This trend was driven by
      the increased supply of fruit and reduction of food prices in general. Still in the pilot
      study survey we tested the acceptance of the introduction of three fruits in the diet of
      participants. The majority of the population accepted without problems to ingest three fruits
      daily. Our initial hypothesis was that fruit consumption in low-income populations would be
      low, which was confirmed. To ensure increased consumption of fruits, these were purchased and
      delivered to the participants, along with transportation vouchers, weekly. The oat cookies
      were also produced by the staff and offered at no cost to the participants. The frequency of
      the number of daily meals was low in the study population at baseline: 3.8 meals per day and
      could encourage major changes in lipid metabolism, associated to the frequency of meals.
      Then, the number of meals was increased to six meals a day, including breakfast, lunch,
      dinner and three snacks between meals and supplement: apple, pear or oat cookies. The dietary
      prescription was based on the eating habits of participants at baseline, changing only the
      number of meals and by introduce fruits or biscuits during treatment.
    

Intervention name(s): Supplement
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): Dietary supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Weight loss; cholesterol