Clinical trial NCT05424042: Health, Aging and Later-Life Outcomes
Official title: Health, Aging and Later-Life Outcomes Pilot Trial (HALLO-P): A 9-month Randomized Pilot Trial of 3 Nutritional Interventions in 120 Older Adults With an Indication for Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: older adults
caloric restriction
time restricted eating
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-06-21
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One-hundred participants (100) will be randomized to the three study arms in a 1:1:1 ratio. Recruitment will be stratified by sex. Once eligibility is established and baseline testing is completed, participants will be randomized using a permuted block scheme with blocks of varying size stratified by sex to one of the 3 intervention groups.
Primary purpose: OTHER

Brief summary: The purpose of this pilot research is to test the feasibility of two interventions focused on either reducing total calorie intake or reducing the total time that calories are ingested each day in older adults. Participation in this research will involve visits to our clinic for testing and weekly intervention visits (in-person or remote depending on group assignment) for nine months with total participation lasting about a year.

Detailed description: This pilot study is part of a larger planning process to design a full-scale randomized trial to evaluate the long-term effects of caloric restriction (CR) and time restricted eating (TRE) on the health of older adults. The specific objective of the HALLO-P is to collect data to inform the design of the full-scale randomized trial to evaluate the long-term effects of caloric restriction and time restricted eating in older adults. The pilot is a 9-month clinical trial. The pilot data will be used to refine recruitment criteria, estimate recruitment yields, and refine intervention approaches.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling men and women residing in Forsyth County, NC or surrounding counties
* obesity (BMI = 30 - \< =40 kg/m2) or are overweight (BMI = 27 - \<30 kg/m2 with an indication for weight loss (e.g., hypertension, hyperlipidemia, elevated waist girth, controlled diabetes)

Exclusion Criteria:

* persons for whom the interventions are potentially unsafe
* history of eating or nutritional disorders
* those who are likely to drop out due to severe chronic illness or other reasons
* who show inability to perform self-monitoring activities required by the interventions
* those doing shift work because disturbances in circadian cycles may interfere with TRE
* uncontrolled or previously undetected diabetes because disease management may interfere with the interventions
* certain medical treatments may complicate outcome interpretation

Primary outcomes:
measure: Degree of sustained CR
timeFrame: Month 9
measure: TRE sustainability
timeFrame: Month 9
measure: Retention of study participants
timeFrame: Month 9
Secondary outcomes:
measure: Body Weight Change
timeFrame: From Baseline to Month 6, and From Baseline to 9 Months
measure: Changes in Fat
timeFrame: From Baseline to Month 9
measure: Changes in Lean Body Mass
timeFrame: From Baseline to Month 9
measure: Change in Bone Mineral Density
timeFrame: From Baseline to Month 9
measure: Change in Resting Energy Expenditure
timeFrame: From Baseline to Month 9
measure: Change in Physical Activity Energy Expenditure
timeFrame: From Baseline to Month 9
measure: Change in Energy Intake
timeFrame: From Baseline to Month 9
measure: Change in Total Muscle Mass
timeFrame: From Baseline to Month 9
measure: Change in Self-Reported Energy Intake
timeFrame: From Baseline to Month 9
measure: Physical Function--Change in Walk Time
timeFrame: From Baseline to Month 9
measure: Physical Function--Change in Grip Strength
timeFrame: From Baseline to Month 9
measure: Physical Function--Change in eSPPB
timeFrame: From Baseline to Month 9
measure: Change in Cognitive Function--MoCA
timeFrame: From baseline to Month 9
measure: Change in Age-Related Biomarkers--Fasting Insulin
timeFrame: From Baseline to 9 Months
measure: Change in Age-Related Biomarkers--interleukin-6 (IL-6)
timeFrame: From Baseline to 9 Months
measure: Change in Age-Related Biomarkers--tumor necrosis factor soluble receptor I (TNFRI)
timeFrame: From Baseline to 9 Months
measure: Change in Age-Related Biomarkers--cystatin C
timeFrame: From Baseline to 9 Months
measure: Change in Age-Related Biomarkers-- CRP from serum
timeFrame: From Baseline to 9 Months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Hospital
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen B. Kritchevsky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Barbara J. Nicklas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Michael E. Miller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: W. Jack Rejeski, PhD
role: PRINCIPAL_INVESTIGATOR
References: