Weight Loss Associated With the Consumption of Apple

NCT01723007 | Completed DMC

• 1 other identifier: ABPM_NCT_APPLE_BR1999
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

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).

Conditions

Hypercholesterolemia; Overweight

Keywords

Weight loss; cholesterol

Outcome Measures

Primary Outcomes (2)

• Cholesterol

  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.

  Ten weeks

• Body weight

  The body weight was evaluated every two weeks.

  Ten weeks

Secondary Outcomes (1)

• Increased triglycerides

  Ten weeks

Other Outcomes (8)

• Caloric and nutrient intakes

  Ten weeks

• Nutritional Composition of Diet

  Ten weekes

• Frequency of meals

  Ten weeks

Study Arms (3)

Other: Apple

EXPERIMENTAL

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

Other: oatmeal cookies

ACTIVE COMPARATOR

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

Other: Pear

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Dietary supplement

Other: Apple; Other: Pear; Other: oatmeal cookies

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

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

Manaus, Amazonas, 69000000, Brazil

Location

Department of Public Health-DSC-FM School of Medicine, Federal University of Amazon-UFAM

Manaus-AM, Amazonas, 69000000, Brazil

Location

Related Publications (16)

• 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.

  PMID: 22575072 BACKGROUND

• 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.

  PMID: 22170373 BACKGROUND

• 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.

  PMID: 17556681 BACKGROUND

• 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.

  PMID: 16002828 BACKGROUND

• 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.

  PMID: 15976148 BACKGROUND

• 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.

  PMID: 7623373 BACKGROUND

• 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.

  PMID: 21251540 BACKGROUND

• 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.

  PMID: 10410299 BACKGROUND

• 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.

  PMID: 10450293 BACKGROUND

• 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.

  PMID: 9099655 BACKGROUND

• 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.

  PMID: 19236172 BACKGROUND

• 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.

  PMID: 8470868 BACKGROUND

• 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.

  PMID: 3827206 BACKGROUND

• 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.

  PMID: 22818725 BACKGROUND

• 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.

  PMID: 18439712 RESULT

• 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.

  PMID: 12620529 RESULT

MeSH Terms

Conditions

Hypercholesterolemia; Overweight; Weight Loss

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maria C De Oliveira, Doctor

  Universidade Federal do Amazonas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor; Associate Professor of Epidemiology

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: November 7, 2012
• Study Start: August 1, 1999
• Primary Completion: June 1, 2000
• Study Completion: June 1, 2001
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

BR (2)