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Completed

NCT Number: NCT01723007

Weight Loss Associated With the Consumption of Apple

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).

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Key information

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health-DSC, School of Medicine-FM, University of Aamazon-UFAM, Manaus, Amazonas, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with hypercholesterolemia,
  • Body Mass Index: IMC > 25 Kg/m2,
  • No smoking,
  • Between 30 to 50 years;
  • Report like apple and pear.

Exclusion criteria

  • Changes in diet in the last 6 months,
  • Making use of controlled medication,
  • Pregnant or lactating women.

Treatment and study plan

Supplement

Other

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 names: Dietary supplement

Primary outcomes

  1. Cholesterol

    Time frame: Ten weeks

    The plasma cholesterol was evaluated every two weeks . After 10 weeks of follow-up the consumption of three apple reduced serum cholesterol, but was not statistically significant.

  2. Body weight

    Time frame: Ten weeks

    The body weight was evaluated every two weeks.

Secondary outcomes

  1. Increased triglycerides

    Time frame: Ten weeks

    Adherence to fruit consumption by participants was evaluated through the changes of serum triglycerides During 4 weeks of follow up.

Other outcomes

  1. Caloric and nutrient intakes

    Time frame: Ten weeks

    To assess adherence to diet and supplements (apple, pear or oat cookies) was used food records twice a week and on weekends.

  2. Nutritional Composition of Diet

    Time frame: Ten weekes

    Food frequency questionnaire was used for analyzing of fiber, calorie content and caloric density on body weight during 10 weeks of follow up. The results were published.

  3. Frequency of meals

    Time frame: Ten weeks

    The frequency of meals daily changes in 10 weeks of follow up were analyzed

  4. Blood Biochemistry

    Time frame: Ten weeks

    The possibility of changes in blood biochemistry for serum urea and serum creatinine, glucose,insulin, haemogram, and lipids fractions during 10 weeks of follow up were analysed. These fractions were not analyzed.

  5. Anthropometry

    Time frame: Ten weeks

    Circumferences (arm, wrist, waist and abdominal), skinfold thickness (biceps, triceps, subscapular, abdominal and calf). Sitting height and standing height in 10 weeks of follow up. Measures are yet to be analyzed.

  6. Blood pressure

    Time frame: Ten weeks

    Blood pressure was evaluated every two weeks during 10 weeks of follow up. The outcomes were not disclosed.

  7. Bioelectrical Impedance

    Time frame: Ten weeks

    The bioelectrical impedance (inductance, resistance) was evaluated to access the phase angle during 10 weeks of follow up. Measures are yet to be analyzed.

  8. Urinalysis

    Time frame: Ten weeks

    Urine analysis was performed to monitor renal function in the three groups (apple, pear and oatmeal cookies), verify changes in urine color and concentration during 10 weeks of follow up. The measures are still being considered.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Amazonas

Other

Collaborators

  • Associação Brasileira de Produtores de Maçã - ABPM
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Hospital Universitario Pedro Ernesto
  • Universidade do Estado do Rio de Janeiro - UERJ

Registry information

Official study title

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

Acronym: NCTAPPLEBR

Important dates

Study start
1999
Primary completion
2000
Study completion
2001
First posted
Nov 7, 2012
Registry last updated
Nov 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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