Skip to main content
OpenTrials
Completed

NCT Number: NCT05424042

Health, Aging and Later-Life Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aging Behavior Fasting Feeding Behavior Intermittent Fasting

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-Person Caloric Restriction

Behavioral

20% CR delivered in-person by dietitian/coach

Remote Caloric Restriction

Behavioral

20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.

Time-restricted

Behavioral

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.

Primary outcomes

  1. Number of Participants That Sustained >10% Caloric Restriction

    Time frame: Month 9

    Ability of participants to sustain Caloric Restriction >10%

  2. Ability to Maintain Time Restricted Eating (TRE) Intervention

    Time frame: Month 9

    This will measure the sustainability in a 9 month period of time and will be reported as the percentage of day eating within <= 8.5 hour window which is pre-specified for each participant.

  3. Number of Participants Who Were Retained

    Time frame: Month 9

    Retention > 85%

Secondary outcomes

  1. Body Weight Change

    Time frame: From Baseline to Month 6, and From Baseline to 9 Months

    Assessed using home scales.

  2. Changes in Fat Mass

    Time frame: From Baseline to Month 9

    Assessed by (Dual-Energy X-Ray Absorptiometry) DXA.

  3. Changes in Lean Body Mass

    Time frame: From Baseline to Month 9

    As assessed by DXA for the total lean body mass.

  4. Change in Bone Mineral Density

    Time frame: From Baseline to Month 9

    As assessed by DXA using the Hip BMD

  5. Change in Resting Energy Expenditure

    Time frame: From Baseline to Month 9

    As assessed by Indirect Calorimetry between baseline and 9 months follow-up

  6. Change in Physical Activity Energy Expenditure

    Time frame: From Baseline to Month 9

    Assessed by ActivPAL

  7. Change in Energy Intake

    Time frame: From Baseline to Month 9

    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

  8. Change in Total Muscle Mass

    Time frame: From Baseline to Month 9

    The D3-Creatine (D3Cr) method used to assess total muscle mass is completed after the participant ingests a known amount of D3-creatine (creatine with deuterium atoms replacing hydrogens) and the labeled creatine is distributed throughout the body, with approximately 98% ending up in skeletal muscle. By measuring the ratio of labeled (D3-creatinine) to unlabeled creatinine in a urine sample the total body creatine pool can be determined and total muscle mass can be calculated.

  9. Change in Self-Reported Energy Intake

    Time frame: From Baseline to Month 9

    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.

  10. Physical Function--Change in Walk Time

    Time frame: From Baseline to Month 9

    400m walk - assessed in number of seconds (unlimited time)

  11. Physical Function--Change in Grip Strength

    Time frame: From Baseline to Month 9

    measured in kg (0-90kg)

  12. Physical Function--Change in eSPPB

    Time frame: From Baseline to Month 9

    Change in overall physical performance with total score ranging from 0 to 4 with a higher score denoting better physical function.

  13. Change in Cognitive Function--MoCA

    Time frame: From baseline to Month 9

    Total score ranges from 0-30 with a higher score denoting better cognitive function.

  14. Change in Age-Related Biomarkers--Fasting Insulin

    Time frame: From Baseline to 9 Months

    Fasting insulin, an age-related biomarker

  15. Change in Age-Related Biomarkers--interleukin-6 (IL-6)

    Time frame: From Baseline to 9 Months

    Interleukin-6 (IL-6) is an Age-related biomarker, cytokine, and key mediator of inflammation

  16. Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI)

    Time frame: From Baseline to 9 Months

    Tumor Necrosis Factor Receptor 1 (TNRFI), an Age-Related Biomarker, is a protein that acts as a receptor for TNF-alpha, a cytokin involved in inflammation.

  17. Change in Age-Related Biomarkers--cystatin C

    Time frame: From Baseline to 9 Months

    Change in cystatin C - An Age-Related Biomarker used to assess kidney function

  18. Change in Age-Related Biomarkers-- CRP From Serum

    Time frame: From Baseline to 9 Months

    Change in C-reactive Protein, an Age-Related Biomarker that is used to detect inflammation in the body

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study 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

Acronym: HALLO-P

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.