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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05424042
Other study ID # IRB00072563
Secondary ID U01AG073240
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 5, 2022
Est. completion date August 31, 2024

Study information

Verified date April 2024
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 90
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
In-Person Caloric Restriction
20% CR delivered in-person by dietitian/coach
Remote Caloric Restriction
20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.
Time-restricted
8-hour TRE with ad libitum caloric intake. This group will undergo a 9-month dietary intervention targeting consumption of all daily caloric intake within an 8-hour window of time, with no restrictions on caloric intake.

Locations

Country Name City State
United States Atrium Health Wake Forest Baptist Hospital Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Wake Forest University Health Sciences National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Degree of sustained CR CR > 10% Month 9
Primary TRE sustainability At least 75% of participants eating within window on >80% of days Month 9
Primary Retention of study participants Retention > 85% Month 9
Secondary Body Weight Change Assessed using home scales. From Baseline to Month 6, and From Baseline to 9 Months
Secondary Changes in Fat Assessed by (Dual-Energy X-Ray Absorptiometry) DXA. From Baseline to Month 9
Secondary Changes in Lean Body Mass Assessed by DXA From Baseline to Month 9
Secondary Change in Bone Mineral Density Assessed by DXA From Baseline to Month 9
Secondary Change in Resting Energy Expenditure Assessed by Indirect Calorimetry From Baseline to Month 9
Secondary Change in Physical Activity Energy Expenditure Assessed by ActivPAL From Baseline to Month 9
Secondary Change in Energy Intake Using doubly-labeled water (DLW). Energy intake will be calculated from Total Energy Expenditure (TEE) assessed by DLW and change in body energy stores (measured by body weight and/or DXA) according to the equation: Energy Intake = TEE + Change in body energy stores From Baseline to Month 9
Secondary Change in Total Muscle Mass Assessed by d3 creatine (d3cr) From Baseline to Month 9
Secondary Change in Self-Reported Energy Intake Data will be collected and nutrients and food groups analyzed using the publicly available National Cancer Institute's Automated Self-Administered 24-Hour (ASA24) dietary assessment tool. From Baseline to Month 9
Secondary Physical Function--Change in Walk Time 400m walk - assessed in minutes/secs (unlimited time) From Baseline to Month 9
Secondary Physical Function--Change in Grip Strength measured in kg (0-90kg) From Baseline to Month 9
Secondary Physical Function--Change in eSPPB Change in overall physical performance with total score ranging from 0 to 12 with a higher score denoting better physical function. From Baseline to Month 9
Secondary Change in Cognitive Function--MoCA Total score ranges from 0-30 with a higher score denoting better cognitive function. From baseline to Month 9
Secondary Change in Age-Related Biomarkers--Fasting Insulin From Baseline to 9 Months
Secondary Change in Age-Related Biomarkers--interleukin-6 (IL-6) From Baseline to 9 Months
Secondary Change in Age-Related Biomarkers--tumor necrosis factor soluble receptor I (TNFRI) From Baseline to 9 Months
Secondary Change in Age-Related Biomarkers--cystatin C and CRP from serum From Baseline to 9 Months
Secondary Change in Age-Related Biomarkers-- CRP from serum From Baseline to 9 Months
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