Weight Loss Associated With the Consumption of Apple (NCTAPPLEBR)
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| ClinicalTrials.gov Identifier: NCT01723007 |
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Recruitment Status :
Completed
First Posted : November 7, 2012
Last Update Posted : November 7, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercholesterolemia Overweight | Other: Supplement | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 49 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Investigator) |
| Official Title: | Modifications of Body Weight and Plasma Lipids With Diet Added of Fruits: Randomized Clinical Trial in Overweight Women |
| Study Start Date : | August 1999 |
| Actual Primary Completion Date : | June 2000 |
| Actual Study Completion Date : | June 2001 |
| Arm | Intervention/treatment |
|---|---|
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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).
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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 |
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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).
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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 |
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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 |
- 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.
- Body weight [ Time Frame: Ten weeks ]The body weight was evaluated every two weeks.
- 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.
- 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.
- 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.
- Frequency of meals [ Time Frame: Ten weeks ]The frequency of meals daily changes in 10 weeks of follow up were analyzed
- 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.
- 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.
- Blood pressure [ Time Frame: Ten weeks ]Blood pressure was evaluated every two weeks during 10 weeks of follow up. The outcomes were not disclosed.
- 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.
- 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.
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| Ages Eligible for Study: | 30 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723007
| Brazil | |
| Department of Public Health-DSC-FM School of Medicine, Federal University of Amazon-UFAM | |
| Manaus-AM, Amazon, Brazil, 69000000 | |
| Department of Public Health-DSC, School of Medicine-FM, University of Aamazon-UFAM | |
| Manaus, Amazon, Brazil, 69000000 | |
| Principal Investigator: | Maria C De Oliveira, Doctor | Universidade Federal do Amazonas |
Other Publications:
| Responsible Party: | Maria Conceição de Oliveira, Doctor; Associate Professor of Epidemiology, Universidade Federal do Amazonas |
| ClinicalTrials.gov Identifier: | NCT01723007 |
| Other Study ID Numbers: |
ABPM_NCT_APPLE_BR1999 |
| First Posted: | November 7, 2012 Key Record Dates |
| Last Update Posted: | November 7, 2012 |
| Last Verified: | November 2012 |
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Weight loss cholesterol |
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Overweight Hypercholesterolemia Overnutrition Nutrition Disorders Body Weight |
Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |