AgingHALLO-PNCT05424042
Health, Aging and Later-Life Outcomes
A study testing In-Person Caloric Restriction, Remote Caloric Restriction and Time-restricted in people with Aging, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging
- What is being tested?
- In-Person Caloric Restriction, Remote Caloric Restriction and Time-restricted
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 22 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157
About this study
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
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.
Read the 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.
- Conditions
- Aging
- Being tested
- In-Person Caloric Restriction, Remote Caloric Restriction, Time-restricted
- Keywords
- older adults, caloric restriction, time restricted eating
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Caloric RestrictionBehavioural
20% CR delivered in-person by dietitian/coach
Remote Caloric RestrictionBehavioural
20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely.
Time-restrictedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| In-Person Caloric Restriction Arm | Experimental | This group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count. Receives: Behavioral: In-Person Caloric Restriction |
| Remote Caloric Restriction Arm | Experimental | This group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing. Receives: Behavioral: Remote Caloric Restriction |
| Time-Restricted Eating Arm | Experimental | 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. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period. Receives: Behavioral: Time-restricted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Sustained >10% Caloric Restriction
Ability of participants to sustain Caloric Restriction >10%
Measured: Month 9
Ability to Maintain Time Restricted Eating (TRE) Intervention
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.
Measured: Month 9
Number of Participants Who Were Retained
Retention > 85%
Measured: Month 9
Secondary outcomes (18)
Body Weight Change
Assessed using home scales.
Measured: From Baseline to Month 6, and From Baseline to 9 Months
Changes in Fat Mass
Assessed by (Dual-Energy X-Ray Absorptiometry) DXA.
Measured: From Baseline to Month 9
Changes in Lean Body Mass
As assessed by DXA for the total lean body mass.
Measured: From Baseline to Month 9
Change in Bone Mineral Density
As assessed by DXA using the Hip BMD
Measured: From Baseline to Month 9
Change in Resting Energy Expenditure
As assessed by Indirect Calorimetry between baseline and 9 months follow-up
Measured: From Baseline to Month 9
Change in Physical Activity Energy Expenditure
Assessed by ActivPAL
Measured: From Baseline to Month 9
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
Measured: From Baseline to Month 9
Change in Total Muscle Mass
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.
Measured: From Baseline to Month 9
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.
Measured: From Baseline to Month 9
Physical Function--Change in Walk Time
400m walk - assessed in number of seconds (unlimited time)
Measured: From Baseline to Month 9
Physical Function--Change in Grip Strength
measured in kg (0-90kg)
Measured: From Baseline to Month 9
Physical Function--Change in eSPPB
Change in overall physical performance with total score ranging from 0 to 4 with a higher score denoting better physical function.
Measured: From Baseline to Month 9
Change in Cognitive Function--MoCA
Total score ranges from 0-30 with a higher score denoting better cognitive function.
Measured: From baseline to Month 9
Change in Age-Related Biomarkers--Fasting Insulin
Fasting insulin, an age-related biomarker
Measured: From Baseline to 9 Months
Change in Age-Related Biomarkers--interleukin-6 (IL-6)
Interleukin-6 (IL-6) is an Age-related biomarker, cytokine, and key mediator of inflammation
Measured: From Baseline to 9 Months
Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI)
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.
Measured: From Baseline to 9 Months
Change in Age-Related Biomarkers--cystatin C
Change in cystatin C - An Age-Related Biomarker used to assess kidney function
Measured: From Baseline to 9 Months
Change in Age-Related Biomarkers-- CRP From Serum
Change in C-reactive Protein, an Age-Related Biomarker that is used to detect inflammation in the body
Measured: From Baseline to 9 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start5 Jul 2022
- Primary completion22 Jul 2024
- Study completion22 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Stephen B. Kritchevsky, PhD, Principal investigator, Wake Forest University Health SciencesBarbara J. Nicklas, PhD, Principal investigator, Wake Forest University Health SciencesMichael E. Miller, PhD, Principal investigator, Wake Forest University Health SciencesW. Jack Rejeski, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424042
- Sponsor's protocol ID
- IRB00072563
- Other IDs
- U01AG073240
- Acronym
- HALLO-P
- Status last verified
- Oct 2025
- First submitted
- 14 Jun 2022
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stowe CL, Kennedy K, Emilson SS, Neiberg RH, Kritchevsky SB, Miller ME, Houston DK, Nicklas BJ, Fanning J, Rejeski WJ; HALLO-P Investigators. The Health, Aging, and Later-Life Outcomes Pilot Study: Design, recruitment, and participants' baseline characteristics. Contemp Clin Trials. 2025 Oct;157:108049. doi: 10.1016/j.cct.2025.108049. Epub 2025 Aug 18.
PubMed 40834924
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05424042
- Acronym / sponsor ID
- HALLO-P / IRB00072563
- Conditions
- Aging
- Keywords
- older adults, caloric restriction, time restricted eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 22 Jul 2024 (actual)
- Study completion
- 22 Jul 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| In-Person Caloric Restriction Arm | Experimental | Behavioral: In-Person Caloric RestrictionThis group will undergo a 9-month behavioral diet intervention targeting a 20% reduction in caloric intake. During the first 6 months, participants will meet in-person one time each month individually and three times/month in a group setting with a dietitian and/or behavioral coach. During the remaining three months of intervention, there will be one group and one individual meeting each month. Participants will keep diet records using the Fitbit app on a tablet and weight using a BodyTrace™ smart scale that transmits data through a study-specific Companion App. Participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, continuously increasing their daily step count. |
| Remote Caloric Restriction Arm | Experimental | Behavioral: Remote Caloric RestrictionThis group will have a 20% reduction in caloric intake and meeting schedule, and physical activity goal similar to the In-Person group. However, the remote arm intervention will be delivered via video conferencing. |
| Time-Restricted Eating Arm | Experimental | Behavioral: Time-restrictedThis 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. During the first 6 months, participants will meet in-person once per month individually and three times per month in a group setting with a dietitian and/or behavioral coach. During the remaining 3 months of intervention, there will be one group and one individual meeting each month. Participants in TRE will be asked to log into the study-specific Companion App each day to document the beginning and end of their feeding cycles with timing of meals/snacks consumed. As in the CR arms, participants will use wrist-worn Fitbit step monitors to track their physical activity and receive feedback via the app, with a goal to promote movement across the day, increasing daily step count. Continuous glucose monitoring will be used at intervals to document glucose levels over a 7-10-day period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-Person Caloric Restriction20% CR delivered in-person by dietitian/coach | Behavioural | In-Person Caloric Restriction Arm |
| Remote Caloric Restriction20% reduction in caloric intake, meeting schedule, and physical activity goal delivered remotely. | Behavioural | Remote Caloric Restriction Arm |
| Time-restricted8-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. | Behavioural | Time-Restricted Eating Arm |
Primary outcome
Number of Participants That Sustained >10% Caloric Restriction
Time frame: Month 9
Ability of participants to sustain Caloric Restriction >10%
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.
Number of Participants Who Were Retained
Time frame: Month 9
Retention > 85%
18 secondary outcomes
Body Weight Change
Time frame: From Baseline to Month 6, and From Baseline to 9 Months
Changes in Fat Mass
Time frame: From Baseline to Month 9
Changes in Lean Body Mass
Time frame: From Baseline to Month 9
Change in Bone Mineral Density
Time frame: From Baseline to Month 9
Change in Resting Energy Expenditure
Time frame: From Baseline to Month 9
Change in Physical Activity Energy Expenditure
Time frame: From Baseline to Month 9
Change in Energy Intake
Time frame: From Baseline to Month 9
Change in Total Muscle Mass
Time frame: From Baseline to Month 9
Change in Self-Reported Energy Intake
Time frame: From Baseline to Month 9
Physical Function--Change in Walk Time
Time frame: From Baseline to Month 9
Physical Function--Change in Grip Strength
Time frame: From Baseline to Month 9
Physical Function--Change in eSPPB
Time frame: From Baseline to Month 9
Change in Cognitive Function--MoCA
Time frame: From baseline to Month 9
Change in Age-Related Biomarkers--Fasting Insulin
Time frame: From Baseline to 9 Months
Change in Age-Related Biomarkers--interleukin-6 (IL-6)
Time frame: From Baseline to 9 Months
Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI)
Time frame: From Baseline to 9 Months
Change in Age-Related Biomarkers--cystatin C
Time frame: From Baseline to 9 Months
Change in Age-Related Biomarkers-- CRP From Serum
Time frame: From Baseline to 9 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40834924Stowe CL, Kennedy K, Emilson SS, Neiberg RH, Kritchevsky SB, Miller ME, Houston DK, Nicklas BJ, Fanning J, Rejeski WJ; HALLO-P Investigators. The Health, Aging, and Later-Life Outcomes Pilot Study: Design, recruitment, and participants' baseline characteristics. Contemp Clin Trials. 2025 Oct;157:108049. doi: 10.1016/j.cct.2025.108049. Epub 2025 Aug 18.
- Individual participant dataSharing planned: No
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen B. Kritchevsky, PhD principal investigator
Wake Forest University Health Sciences
Barbara J. Nicklas, PhD principal investigator
Wake Forest University Health Sciences
Michael E. Miller, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Person Caloric Restriction, Remote Caloric Restriction and Time-restricted in people with Aging, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Sustained >10% Caloric Restriction (time frame: Month 9). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05424042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.