Health, Aging and Later-Life Outcomes

Aging Clinical Trial

— HALLO-P  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Aging

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