Weight Loss Associated With the Consumption of Apple (NCTAPPLEBR)

This study has been completed.
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Associação Brasileira de Produtores de Maçã - ABPM
Hospital Universitário Pedro Ernesto - HUPE
Universidade do Estado do Rio de Janeiro - UERJ
Information provided by (Responsible Party):
Maria Conceição de Oliveira, Universidade Federal do Amazonas
ClinicalTrials.gov Identifier:
NCT01723007
First received: October 9, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention
Hypercholesterolemia
Overweight
Other: Supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Modifications of Body Weight and Plasma Lipids With Diet Added of Fruits: Randomized Clinical Trial in Overweight Women

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Amazonas:

Primary Outcome Measures:
  • Cholesterol [ Time Frame: Ten weeks ] [ Designated as safety issue: Yes ]
    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.

  • Body weight [ Time Frame: Ten weeks ] [ Designated as safety issue: Yes ]
    The body weight was evaluated every two weeks.


Secondary Outcome Measures:
  • Increased triglycerides [ Time Frame: Ten weeks ] [ Designated as safety issue: Yes ]
    Adherence to fruit consumption by participants was evaluated through the changes of serum triglycerides During 4 weeks of follow up.


Other Outcome Measures:
  • Caloric and nutrient intakes [ Time Frame: Ten weeks ] [ Designated as safety issue: Yes ]
    To assess adherence to diet and supplements (apple, pear or oat cookies) was used food records twice a week and on weekends.

  • Nutritional Composition of Diet [ Time Frame: Ten weekes ] [ Designated as safety issue: Yes ]
    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.

  • Frequency of meals [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
    The frequency of meals daily changes in 10 weeks of follow up were analyzed

  • Blood Biochemistry [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
    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.

  • Anthropometry [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
    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.

  • Blood pressure [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
    Blood pressure was evaluated every two weeks during 10 weeks of follow up. The outcomes were not disclosed.

  • Bioelectrical Impedance [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
    The bioelectrical impedance (inductance, resistance) was evaluated to access the phase angle during 10 weeks of follow up. Measures are yet to be analyzed.

  • Urinalysis [ Time Frame: Ten weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: August 1999
Study Completion Date: June 2001
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Other: Apple
Women were supplemented with apples. Sixteen women were asked to ingest three apple daily between meals ( approximately 120g kcal) between meals (breakfast, lunch and dinner).
Other: Supplement
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 Name: Dietary supplement
Active Comparator: Other: oatmeal cookies
A another group with nineteen women were asked to ingest three oatmeal cookies a day, approximately 60g and similar caloric content to experimental group (approximately 120 kcal) between meals (breakfast, lunch and dinner).
Other: Supplement
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 Name: Dietary supplement
Active Comparator: Other: Pear
Women were supplemented with pear. Sixteen women were asked to ingest daily three pears (approximately 120 kcal) between meals daily (breakfast, lunch and dinner).
Other: Supplement
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 Name: Dietary supplement

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.

  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01723007

Locations
Brazil
Department of Public Health-DSC, School of Medicine-FM, University of Aamazon-UFAM
Manaus, Amazon, Brazil, 69000000
Department of Public Health-DSC-FM School of Medicine, Federal University of Amazon-UFAM
Manaus-AM, Amazon, Brazil, 69000000
Sponsors and Collaborators
Universidade Federal do Amazonas
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Associação Brasileira de Produtores de Maçã - ABPM
Hospital Universitário Pedro Ernesto - HUPE
Universidade do Estado do Rio de Janeiro - UERJ
Investigators
Principal Investigator: Maria C De Oliveira, Doctor Universidade Federal do Amazonas
  More Information

Publications:
Vergnaud AC, Norat T, Romaguera D, Mouw T, May AM, Romieu I, Freisling H, Slimani N, Boutron-Ruault MC, Clavel-Chapelon F, Morois S, Kaaks R, Teucher B, Boeing H, Buijsse B, Tjønneland A, Halkjaer J, Overvad K, Jakobsen MU, Rodríguez L, Agudo A, Sánchez MJ, Amiano P, Huerta JM, Gurrea AB, Wareham N, Khaw KT, Crowe F, Orfanos P, Naska A, Trichopoulou A, Masala G, Pala V, Tumino R, Sacerdote C, Mattiello A, Bueno-de-Mesquita HB, van Duijnhoven FJ, Drake I, Wirfält E, Johansson I, Hallmans G, Engeset D, Braaten T, Parr CL, Odysseos A, Riboli E, Peeters PH. Fruit and vegetable consumption and prospective weight change in participants of the European Prospective Investigation into Cancer and Nutrition-Physical Activity, Nutrition, Alcohol, Cessation of Smoking, Eating Out of Home, and Obesity study. Am J Clin Nutr. 2012 Jan;95(1):184-93. Epub 2011 Dec 14.

Responsible Party: Maria Conceição de Oliveira, Doctor; Associate Professor of Epidemiology, Universidade Federal do Amazonas
ClinicalTrials.gov Identifier: NCT01723007     History of Changes
Other Study ID Numbers: ABPM_NCT_APPLE_BR1999
Study First Received: October 9, 2012
Last Updated: November 6, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Amazonas:
Weight loss
cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Overweight
Body Weight
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014