Clinical trial NCT02033655: A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women
Official title: A High Protein Weight Loss Intervention for Sarcopenic Obesity in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Obesity
Keywords: weight loss
older adults
obesity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Pork Board
First posted: 2014-01-13
Enrollment: 105
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

For 6 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 20) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 40) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of \> 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from pork. Subject criteria will include obese (\>30 kg/m2) women (≥ 45 yrs.) with mild to moderate functional impairment (by 6 minute walk).

For 9 month intervention: Participants will be randomized into one of two study arms: Weight Loss Control (n = 10) subjects follow a calorie-reduced diet for a weight loss or ≥10%; or Weight Loss-High Protein: (n = 10) subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein at each meal. Intakes of \> 30g of high quality protein will be achieved three times a day by subjects in this group, predominantly all from animal sources and 60-70% of animal protein from pork. Subject criteria will include obese (≥ 30 kg/m2) women (≥ 60 yrs.) with mild to moderate functional impairment (by 6 minute walk).

This is a randomized clinical trial with repeated measurements, with the purpose of assessing change over time for the overall sample and the difference in the High Protein group relative to the Control group with regards to primary outcomes (function and lean body mass). The statistical analyses will proceed chronologically in 3 phases: 1) descriptive analyses that will summarize the distribution of the covariates and dependent variables, 2) bivariate analyses of the association between group membership and the outcome measures, and 3) controlled multivariable analyses, which assess the association between experimental group and the outcomes, controlling for the important covariates.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Physical function
timeFrame: Baseline, 4, 6, and 9 months
measure: Lean Mass
timeFrame: Baseline, 4, 6, and 9 months
Secondary outcomes:
measure: Physical Function
timeFrame: Baseline, 4, 6, and 9 months
measure: Weight Loss
timeFrame: Baseline, 4, 6, and 9 months
measure: Fat Mass
timeFrame: Baseline, 4, 6, and 9 months
Other outcomes:
measure: Change in baseline lipid classes at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline lipid subclasses at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline lipid participle sizes at 6 months
timeFrame: Baseline to 6 months
measure: Changes in baseline GlycA at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline trimethylamine-N-oxide (TMAO) at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline betaine at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline Lipoprotein Insulin Resistance Index (LP-IR) scores at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline Estimated GFR at 6 months
timeFrame: Baseline to 6 months
measure: Change in baseline fasting glucose at 6 months
timeFrame: Baseline to 6 months
Locations:
city: Durham
country: United States
facility: Duke Universtiy Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Connie W Bales, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.