Clinical trial NCT00955903: Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Official title: Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Diabetes
Hypertension
Hyperlipidemia
Keywords: glucose
insulin
lipids
C-reactive protein
adiponectin
leptin
TNF alpha
IL-6
Quality of Life
functional status
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2009-08-10
Enrollment: 167
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.


Eligibility criteria: Inclusion Criteria:

* at least 65 years of age
* BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes)

Exclusion Criteria:

* difficulties chewing or swallowing food
* digestive diseases that may affect the ability to follow a high fiber diet
* cognitive impairment
* depression
* recent weight change (+/- 10 lbs in the last 12 months)
* poorly controlled blood pressure
* history of non-skin cancer in last 5 years
* cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure
* major liver dysfunction
* current smoker or quit less than months prior
* history of prior surgical procedures for weight control or liposuction
* use of estrogen or testosterone replacement therapy
* current use of insulin or sulfonylurea agents
* current use of corticosteroids \> 5 days/month on average
* current use of medications for treatment of psychosis or manic-depressive illness
* use of weight-loss medications in previous 3 months
* dependence on others for food procurement or preparation
* ischemic changes on exercise treadmill test

Primary outcomes:
measure: Change in Abdominal Fat Mass
timeFrame: Baseline to 1 year
Secondary outcomes:
measure: Cardiometabolic Risk Factors
timeFrame: Baseline to 1 year
measure: Weight Change/Maintenance
timeFrame: Baseline to 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jamy D Ard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Julie Locher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Senkus KE, Crowe-White KM, Bolland AC, Locher JL, Ard JD. Changes in adiponectin:leptin ratio among older adults with obesity following a 12-month exercise and diet intervention. Nutr Diabetes. 2022 Jun 2;12(1):30. doi: 10.1038/s41387-022-00207-1.
citation: Senkus KE, Crowe-White KM, Locher JL, Ard JD. Relative fat mass assessment estimates changes in adiposity among female older adults with obesity after a 12-month exercise and diet intervention. Ann Med. 2022 Dec;54(1):1160-1166. doi: 10.1080/07853890.2022.2067352.
citation: Bragg AE, Crowe-White KM, Ellis AC, Studer M, Phillips F, Samsel S, Parton J, Locher JL, Ard JD. Changes in Cardiometabolic Risk Among Older Adults with Obesity: An Ancillary Analysis of a Randomized Controlled Trial Investigating Exercise Plus Weight Maintenance and Exercise Plus Intentional Weight Loss by Caloric Restriction. J Acad Nutr Diet. 2022 Feb;122(2):354-362. doi: 10.1016/j.jand.2021.07.009. Epub 2021 Sep 1.
citation: Crowe-White KM, Ellis AC, Mehta T, Locher JL, Ard JD. Dietary Quality Assessed by the HEI-2010 and Biomarkers of Cardiometabolic Disease: An Exploratory Analysis. J Am Coll Nutr. 2019 Sep-Oct;38(7):640-647. doi: 10.1080/07315724.2019.1580168. Epub 2019 May 30.