The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy

Weight Loss Clinical Trial

Official title:

The Beef WISE Study: Beef's Role in Weight Improvement, Satisfaction, and Energy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627105
• Other study ID #: 15-0989
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study will compare two protein sources: proteins to include beef as the sole source of red meat compared to proteins excluding red meat within the context of an effective higher-protein weight loss and maintenance program derived from the Colorado Diet.

All subjects will participate in a group-based program consisting of 16 weekly classes in 3-phases designed to produce weight loss and teach participants how to achieve a lifestyle to keep weight off permanently. All groups will be closed (same subjects, same leader) and will consist of 20 participants. Participants in both groups will receive instruction in cooking, recipes, and shopping instruction (using our grocery laboratory). This training will include strategies, tips and preparation techniques for preparing high protein meals according to their assigned groups. All subjects are given exercise plans and all subjects will receive memberships to the Anschutz Health and Wellness Center fitness center for the duration of the study.

After completion of the 16-week program, subjects will be asked to follow the program on their own for an additional 2 months.

This is a randomized study involving 120 study subjects (60 per arm). The investigators will compare the efficacy of inducing weight loss of two treatment arms derived from the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the higher-protein diet by participating in weekly group classes for the first four months of the study. There will be 6 classes of 20 subjects each (three classes for each treatment group). Subjects will be followed in the study for 6 months. Subjects will be randomized into one of two treatment groups as follows:

• Group 1(SOS+B): Subjects will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will receive stipends to be used to help purchase protein food items allowed in the Colorado Diet as modified. The Colorado diet is a high protein (estimated 120-160g/day), low carb and low fat diet. Subjects will be directed and instructed to include beef as their sole source of red meat as a protein source during the study. Subjects will follow the diet protein guidelines, but will be directed and instructed to consume 4 or more servings of beef per week and instructed not to consume any other red meats. Other red meats to be avoided include pork, veal, lamb, buffalo and venison. Subjects will be advised to use the monetary stipends to purchase items from the lists of acceptable foods from the SOS book (to include beef products). Processed beef items will be allowed as identified by a list provided to the subjects.

• Group 2 (SOS): Subjects will participate in a State of Slim class, receive the State of Slim book (describing the Colorado Diet), and will receive stipends to be used to help purchase protein food items allowed in the Colorado diet as modified. Subjects will be directed and instructed to exclude beef and instructed not to consume any other red meats. Other red meats to be avoided include pork, veal, lamb, buffalo, and venison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Males and females between 18 - 50 years old

2. BMI of 27 or greater

3. Weight stable (have not lost or gained more than 10 pounds in the last 3 months)

4. Generally healthy

5. Able to exercise 70 minutes per day at moderate intensity

6. 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

Exclusion Criteria:

1. Pregnant or trying to become pregnant.

2. Diagnosis of type 1 or type 2 diabetes

3. Individuals following a vegetarian/vegan only diet

4. Food allergies (to red meats or other common protein sources)

5. 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.

6. Current Eating disorder (anorexia or bulimia)

7. 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).

8. Any medical condition for which following a high protein diet and/or 70 minutes of exercise daily would be inadvisable

9. LDL cholesterol levels above 160 mg/dl or triglycerides above 400 mg/dl.

10. Untreated or unstable hypothyroidism. Thyroid medications must be stable for at least 3 months.

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cattlemen's Beef Association

Country where clinical trial is conducted

United States, 

References & Publications (19)

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Barkeling B, Rössner S, Björvell 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. — View Citation

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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. — View Citation

Foster, G.D., Wyatt, H.R., Hill, J.O., McGuckin, B.G., Brill, C., Mohammed, S., Szapary, P.O., Rader, D.J., Edman, J.S. , and Klein, S. A multi-center, randomized, controlled clinical trial of the Atkins diet. N Engl J Med 348:282-290, 2003. PMID: 12761365.

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.

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. — View Citation

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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. Review. — View Citation

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.

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. — View Citation

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. — View Citation

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). pii: E700. doi: 10.3 — View Citation

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. eColle — View Citation

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. — View Citation

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. — View Citation

Westerterp-Plantenga MS, Nieuwenhuizen A, Tomé 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. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in % body fat at the end of a 16 week period		16 weeks
Secondary	Change from baseline in lipid panel results at end of 16 week period and end of 6 month period		16 weeks and 6 months
Secondary	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
Secondary	Change from baseline in hemoglobin A1C results at end of 16 week period and end of 6 month period.		16 weeks and 6 months
Secondary	Differences in responses to study questionnaires between the two groups regarding satisfaction with the weight loss program.		6 months
Secondary	Differences in responses to study questionnaires between the two groups regarding adherence to the weight loss program.		6 months