NCT02627105

Brief Summary

This is a 6 month long study to evaluate the inclusion or exclusion of beef within a weight loss program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

December 3, 2015

Last Update Submit

November 6, 2018

Conditions

Keywords

weight lossred meatsobesitylean body massbody compositiondietary protein

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in % body weight at the end of a 16 week period and at the end of the 6 month period

    16 weeks and 6 months

Secondary Outcomes (6)

  • Change from baseline in % body fat at the end of a 16 week period

    16 weeks

  • Change from baseline in lipid panel results at end of 16 week period and end of 6 month period

    16 weeks and 6 months

  • Change from baseline in fasting blood glucose results at end of 16 week period and end of 6 month period.

    16 weeks and 6 months

  • Change from baseline in hemoglobin A1C results at end of 16 week period and end of 6 month period.

    16 weeks and 6 months

  • Differences in responses to study questionnaires between the two groups regarding satisfaction with the weight loss program.

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Beef group

EXPERIMENTAL

Subjects in this group are asked to consume 4 or more servings of beef per week and to exclude all other red meats from their diet for the 6 month study.

Behavioral: Beef group

Non-beef group

OTHER

Subjects in this group are asked to avoid all red meats from their diet for the 6 month study.

Behavioral: Non-beef group

Interventions

Beef groupBEHAVIORAL

Subjects in the beef group will be asked to consume 4 or more servings of beef per week (and to avoid all other red meats) during the 6 month study.

Beef group
Non-beef groupBEHAVIORAL

Subjects in the non-beef group will be asked to avoid all red meats during the 6 month study.

Non-beef group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females between 18 - 50 years old
  • BMI of 27 or greater
  • Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
  • Generally healthy
  • Able to exercise 70 minutes per day at moderate intensity
  • Willing and able to participate in a weekly group class for the first 16 weeks of the study and willing to participate in 4 study visits over the 6 month study period

You may not qualify if:

  • Pregnant or trying to become pregnant.
  • Diagnosis of type 1 or type 2 diabetes
  • Individuals following a vegetarian/vegan only diet
  • Food allergies (to red meats or other common protein sources)
  • Taking medications that could cause weight loss or weight gain (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over the counter weight loss agents). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Vitamins and minerals which do not have a weight effect are allowed as long as use is continued without change during the study.
  • Current Eating disorder (anorexia or bulimia)
  • Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
  • Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable
  • LDL cholesterol levels above 160 mg/dl or triglycerides above 400 mg/dl.
  • Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (20)

  • Anderson GH, Moore SE. Dietary proteins in the regulation of food intake and body weight in humans. J Nutr. 2004 Apr;134(4):974S-9S. doi: 10.1093/jn/134.4.974S.

    PMID: 15051857BACKGROUND
  • Anderson GH, Tecimer SN, Shah D, Zafar TA. Protein source, quantity, and time of consumption determine the effect of proteins on short-term food intake in young men. J Nutr. 2004 Nov;134(11):3011-5. doi: 10.1093/jn/134.11.3011.

    PMID: 15514267BACKGROUND
  • Barkeling B, Rossner S, Bjorvell H. Effects of a high-protein meal (meat) and a high-carbohydrate meal (vegetarian) on satiety measured by automated computerized monitoring of subsequent food intake, motivation to eat and food preferences. Int J Obes. 1990 Sep;14(9):743-51.

    PMID: 2228407BACKGROUND
  • Booth DA, Chase A, Campbell AT. Relative effectiveness of protein in the late stages of appetite suppression in man. Physiol Behav. 1970 Nov;5(11):1299-302. doi: 10.1016/0031-9384(70)90044-2. No abstract available.

    PMID: 5524514BACKGROUND
  • Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.

    PMID: 16735482BACKGROUND
  • Foster GD, Wyatt HR, Hill JO, McGuckin BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman JS, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med. 2003 May 22;348(21):2082-90. doi: 10.1056/NEJMoa022207.

    PMID: 12761365BACKGROUND
  • Latner JD, Schwartz M. The effects of a high-carbohydrate, high-protein or balanced lunch upon later food intake and hunger ratings. Appetite. 1999 Aug;33(1):119-28. doi: 10.1006/appe.1999.0237.

    PMID: 10447984BACKGROUND
  • Donnelly JE, Hill JO, Jacobsen DJ, Potteiger J, Sullivan DK, Johnson SL, Heelan K, Hise M, Fennessey PV, Sonko B, Sharp T, Jakicic JM, Blair SN, Tran ZV, Mayo M, Gibson C, Washburn RA. Effects of a 16-month randomized controlled exercise trial on body weight and composition in young, overweight men and women: the Midwest Exercise Trial. Arch Intern Med. 2003 Jun 9;163(11):1343-50. doi: 10.1001/archinte.163.11.1343.

    PMID: 12796071BACKGROUND
  • Hill, J. H. & Blundell, J. E. (1986) Macronutrients and satiety: The effects of a high-protein or high-carbohydrate meal on subjective motivation to eat and food preferences. Nutr. Behav. 3: 133-144.

    BACKGROUND
  • Marmonier C, Chapelot D, Louis-Sylvestre J. Effects of macronutrient content and energy density of snacks consumed in a satiety state on the onset of the next meal. Appetite. 2000 Apr;34(2):161-8. doi: 10.1006/appe.1999.0302.

    PMID: 10744905BACKGROUND
  • Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.

    PMID: 18469287BACKGROUND
  • Peters, J.C. Control of Energy Balance. In: Biochemical, physiological, molecular aspects of human nutrition. Second edition, M.H. Stipanuk ed. Saunders Elsevier, 2006, pp. 618-639.

    BACKGROUND
  • Porrini M, Santangelo A, Crovetti R, Riso P, Testolin G, Blundell JE. Weight, protein, fat, and timing of preloads affect food intake. Physiol Behav. 1997 Sep;62(3):563-70. doi: 10.1016/s0031-9384(97)00162-5.

    PMID: 9272665BACKGROUND
  • Rolls BJ, Hetherington M, Burley VJ. The specificity of satiety: the influence of foods of different macronutrient content on the development of satiety. Physiol Behav. 1988;43(2):145-53. doi: 10.1016/0031-9384(88)90230-2.

    PMID: 3212049BACKGROUND
  • Veldhorst MA, Nieuwenhuizen AG, Hochstenbach-Waelen A, van Vught AJ, Westerterp KR, Engelen MP, Brummer RJ, Deutz NE, Westerterp-Plantenga MS. Dose-dependent satiating effect of whey relative to casein or soy. Physiol Behav. 2009 Mar 23;96(4-5):675-82. doi: 10.1016/j.physbeh.2009.01.004.

    PMID: 19385022BACKGROUND
  • Wadden TA, Foreyt JP, Foster GD, Hill JO, Klein S, O'Neil PM, Perri MG, Pi-Sunyer FX, Rock CL, Erickson JS, Maier HN, Kim DD, Dunayevich E. Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification: the COR-BMOD trial. Obesity (Silver Spring). 2011 Jan;19(1):110-20. doi: 10.1038/oby.2010.147. Epub 2010 Jun 17.

    PMID: 20559296BACKGROUND
  • Westerterp-Plantenga MS, Nieuwenhuizen A, Tome D, Soenen S, Westerterp KR. Dietary protein, weight loss, and weight maintenance. Annu Rev Nutr. 2009;29:21-41. doi: 10.1146/annurev-nutr-080508-141056.

    PMID: 19400750BACKGROUND
  • Sayer RD, Speaker KJ, Pan Z, Peters JC, Wyatt HR, Hill JO. Equivalent reductions in body weight during the Beef WISE Study: beef's role in weight improvement, satisfaction and energy. Obes Sci Pract. 2017 Jul 11;3(3):298-310. doi: 10.1002/osp4.118. eCollection 2017 Sep.

  • Sayer RD, Peters JC, Pan Z, Wyatt HR, Hill JO. Hunger, Food Cravings, and Diet Satisfaction are Related to Changes in Body Weight During a 6-Month Behavioral Weight Loss Intervention: The Beef WISE Study. Nutrients. 2018 May 31;10(6):700. doi: 10.3390/nu10060700.

  • Clina JG, Pan Z, Wyatt HR, Peters JC, Hill JO, Sayer RD. Secondary analysis of a university-based weight loss program in on-campus versus off-campus employees. Obes Sci Pract. 2022 Jun 4;8(6):767-774. doi: 10.1002/osp4.618. eCollection 2022 Dec.

MeSH Terms

Conditions

Weight LossObesity

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • James O Hill, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 10, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations