A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women

NCT02033655 | Completed DMC

• 1 other identifier: Pro00050540
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (primarily from lean pork and other animal source proteins) with calorie restriction on functional status and lean muscle mass in frail, obese, women who participate in a 6 month intervention and 9 month intervention.

Conditions

Weight Loss; Obesity

Keywords

weight loss; older adults; obesity

Outcome Measures

Primary Outcomes (2)

• Physical function

  Assess the change in 6 minute walk scores at 4, 6, and 9 months

  Baseline, 4, 6, and 9 months

• Lean Mass

  To assess the change in lean mass at 3 or 4 time points.

  Baseline, 4, 6, and 9 months

Secondary Outcomes (3)

• Physical Function

  Baseline, 4, 6, and 9 months

• Weight Loss

  Baseline, 4, 6, and 9 months

• Fat Mass

  Baseline, 4, 6, and 9 months

Other Outcomes (9)

• Change in baseline lipid classes at 6 months

  Baseline to 6 months

• Change in baseline lipid subclasses at 6 months

  Baseline to 6 months

• Change in baseline lipid participle sizes at 6 months

  Baseline to 6 months

Study Arms (2)

Weight loss high protein

EXPERIMENTAL

Protein supplementation. Subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of protein, including substantial amounts of supplemental protein provided as lean beef. Intakes of \> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60% of animal protein from pork.

Dietary Supplement: Protein supplementation; Behavioral: Diet counseling and group education lessons

Weight loss control

ACTIVE COMPARATOR

Diet counseling and group education lessons. Subjects follow a calorie-reduction diet for a weight loss of ≥10%.

Behavioral: Diet counseling and group education lessons

Interventions

Protein supplementation DIETARY_SUPPLEMENT

\> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from lean pork.

Weight loss high protein

Diet counseling and group education lessons BEHAVIORAL

Participants meet once a week for 6 months to participate in group lessons and counseling.

Weight loss control; Weight loss high protein

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 45+ yrs.
• BMI of \>30 kg/m2
• Body weight \<495 lbs.
• Normal blood chemistries
• Normal renal function
• Primary care physician acknowledgement
• Non-Vegetarian
• Mild to moderate movement impairment

You may not qualify if:

• Body weight \>495 pounds.
• Current smoker.
• Presence of unstable, acutely symptomatic, or life-limiting illness.
• Positive screen for dementia using Mini-Cog evaluation tool.
• Neurological conditions causing functional or cognitive impairments.
• History of significant weight instability (defined as \> 10 pounds weight gain or loss over 6 months prior to study participation).
• Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing or continuously participate in a randomly assigned lifestyle intervention program for six months.
• Inability to walk independently.
• Bilateral hip replacements.
• Unable to give consent.
• Unable to complete written recording forms including journals of eating and exercise behaviors.
• Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications.
• Primary Care Physician advises against participation.

Sponsors & Collaborators

• Duke University: lead
• National Pork Board: collaborator

Study Sites (1)

Duke Universtiy Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Bales CW, Porter Starr KN, Orenduff MC, McDonald SR, Molnar K, Jarman AK, Onyenwoke A, Mulder H, Payne ME, Pieper CF. Influence of Protein Intake, Race, and Age on Responses to a Weight-Reduction Intervention in Obese Women. Curr Dev Nutr. 2017 May 1;1(5):e000703. doi: 10.3945/cdn.117.000703. Epub 2017 Apr 11.

  PMID: 29517074 DERIVED

MeSH Terms

Conditions

Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Connie W Bales, PhD, RD

  Duke University

  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: January 9, 2014
• First Posted: January 13, 2014
• Study Start: March 1, 2014
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: January 8, 2019

Record last verified: 2018-09

Locations

US (1)