Clinical trial NCT01723007: Weight Loss Associated With the Consumption of Apple
Official title: Modifications of Body Weight and Plasma Lipids With Diet Added of Fruits: Randomized Clinical Trial in Overweight Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Overweight
Keywords: Weight loss
cholesterol
Lead sponsor: Universidade Federal do Amazonas
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Associação Brasileira de Produtores de Maçã - ABPM
name: Hospital Universitario Pedro Ernesto
name: Universidade do Estado do Rio de Janeiro - UERJ
First posted: 2012-11-07
Enrollment: 49
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Cholesterol
timeFrame: Ten weeks
measure: Body weight
timeFrame: Ten weeks
Secondary outcomes:
measure: Increased triglycerides
timeFrame: Ten weeks
Other outcomes:
measure: Caloric and nutrient intakes
timeFrame: Ten weeks
measure: Nutritional Composition of Diet
timeFrame: Ten weekes
measure: Frequency of meals
timeFrame: Ten weeks
measure: Blood Biochemistry
timeFrame: Ten weeks
measure: Anthropometry
timeFrame: Ten weeks
measure: Blood pressure
timeFrame: Ten weeks
measure: Bioelectrical Impedance
timeFrame: Ten weeks
measure: Urinalysis
timeFrame: Ten weeks
Locations:
city: Manaus-AM
country: Brazil
facility: Department of Public Health-DSC-FM School of Medicine, Federal University of Amazon-UFAM
state: Amazon
city: Manaus
country: Brazil
facility: Department of Public Health-DSC, School of Medicine-FM, University of Aamazon-UFAM
state: Amazon
Study officials:
affiliation: Universidade Federal do Amazonas
name: Maria C De Oliveira, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raynor HA, Looney SM, Steeves EA, Spence M, Gorin AA. The effects of an energy density prescription on diet quality and weight loss: a pilot randomized controlled trial. J Acad Nutr Diet. 2012 Sep;112(9):1397-1402. doi: 10.1016/j.jand.2012.02.020. Epub 2012 May 9.
citation: 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, Tjonneland A, Halkjaer J, Overvad K, Jakobsen MU, Rodriguez L, Agudo A, Sanchez 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, Wirfalt 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. doi: 10.3945/ajcn.111.019968. Epub 2011 Dec 14.
citation: Ello-Martin JA, Roe LS, Ledikwe JH, Beach AM, Rolls BJ. Dietary energy density in the treatment of obesity: a year-long trial comparing 2 weight-loss diets. Am J Clin Nutr. 2007 Jun;85(6):1465-77. doi: 10.1093/ajcn/85.6.1465.
citation: Ello-Martin JA, Ledikwe JH, Rolls BJ. The influence of food portion size and energy density on energy intake: implications for weight management. Am J Clin Nutr. 2005 Jul;82(1 Suppl):236S-241S. doi: 10.1093/ajcn/82.1.236S.
citation: Rolls BJ, Roe LS, Beach AM, Kris-Etherton PM. Provision of foods differing in energy density affects long-term weight loss. Obes Res. 2005 Jun;13(6):1052-60. doi: 10.1038/oby.2005.123.
citation: Singh RB, Niaz MA, Bishnoi I, Singh U, Begum R, Rastogi SS. Effect of low energy diet and weight loss on major risk factors, central obesity and associated disturbances in patients with essential hypertension. J Hum Hypertens. 1995 May;9(5):355-62.
citation: Lin J, Fung TT, Hu FB, Curhan GC. Association of dietary patterns with albuminuria and kidney function decline in older white women: a subgroup analysis from the Nurses' Health Study. Am J Kidney Dis. 2011 Feb;57(2):245-54. doi: 10.1053/j.ajkd.2010.09.027.
citation: Sacks FM, Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A dietary approach to prevent hypertension: a review of the Dietary Approaches to Stop Hypertension (DASH) Study. Clin Cardiol. 1999 Jul;22(7 Suppl):III6-10. doi: 10.1002/clc.4960221503.
citation: Lin PH, Windhauser MM, Plaisted CS, Hoben KP, McCullough ML, Obarzanek E. The Linear Index Model for establishing nutrient goals in the Dietary Approaches to Stop Hypertension trial. DASH Collaborative Research Group. J Am Diet Assoc. 1999 Aug;99(8 Suppl):S40-4. doi: 10.1016/s0002-8223(99)00415-0.
citation: Appel LJ, Moore TJ, Obarzanek E, Vollmer WM, Svetkey LP, Sacks FM, Bray GA, Vogt TM, Cutler JA, Windhauser MM, Lin PH, Karanja N. A clinical trial of the effects of dietary patterns on blood pressure. DASH Collaborative Research Group. N Engl J Med. 1997 Apr 17;336(16):1117-24. doi: 10.1056/NEJM199704173361601.
citation: Hyson D, Studebaker-Hallman D, Davis PA, Gershwin ME. Apple juice consumption reduces plasma low-density lipoprotein oxidation in healthy men and women. J Med Food. 2000 Winter;3(4):159-66. doi: 10.1089/jmf.2000.3.159.
citation: Sable-Amplis R, Sicart R. Hepatic acylcoenzyme A:cholesterol acyltransferase activity is low in hamsters fed apples in addition to a standard diet. Ann Nutr Metab. 1993;37(1):1-7. doi: 10.1159/000177742.
citation: Sable-Amplis R, Sicart R, Dupouy D. Hepatic cholesterogenesis and cholesterol 7 alpha-hydroxylase activity in hamsters fed diets enriched with pectins and/or cholesterol. Ann Nutr Metab. 1987;31(1):61-8. doi: 10.1159/000177249.
citation: Chai SC, Hooshmand S, Saadat RL, Payton ME, Brummel-Smith K, Arjmandi BH. Daily apple versus dried plum: impact on cardiovascular disease risk factors in postmenopausal women. J Acad Nutr Diet. 2012 Aug;112(8):1158-68. doi: 10.1016/j.jand.2012.05.005.
citation: de Oliveira MC, Sichieri R, Venturim Mozzer R. A low-energy-dense diet adding fruit reduces weight and energy intake in women. Appetite. 2008 Sep;51(2):291-5. doi: 10.1016/j.appet.2008.03.001. Epub 2008 Mar 7.
citation: Conceicao de Oliveira M, Sichieri R, Sanchez Moura A. Weight loss associated with a daily intake of three apples or three pears among overweight women. Nutrition. 2003 Mar;19(3):253-6. doi: 10.1016/s0899-9007(02)00850-x.