← Back to Search

Caloric Restriction for Aging(HALLO-P Trial)

N/A

Recruiting

Led By W. Jack Rejeski, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upfrom baseline to month 6, and from baseline to 9 months

Awards & highlights

No Placebo-Only Group

HALLO-P Trial Summary

This trial is testing whether reducing calories or the time spent eating leads to better health outcomes in older adults.

HALLO-P Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to month 6, and from baseline to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to month 6, and from baseline to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to month 6, and from baseline to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Degree of sustained CR

Retention of study participants

TRE sustainability

Secondary outcome measures

Body Weight Change

Change in Age-Related Biomarkers-- CRP from serum

Change in Age-Related Biomarkers--Fasting Insulin

+15 more

Other outcome measures

Community Interest

Intervention Delivery Costs

Participants with Inter-current Health Events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

HALLO-P Trial Design

3Treatment groups

Experimental Treatment

Group I: Time-Restricted Eating ArmExperimental Treatment1 Intervention

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.

Group II: Remote Caloric Restriction ArmExperimental Treatment1 Intervention

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.

Group III: In-Person Caloric Restriction ArmExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,208 Previous Clinical Trials

1,030,047 Total Patients Enrolled

9 Trials studying Aging

4,792 Patients Enrolled for Aging

W. Jack Rejeski, PhDPrincipal InvestigatorWake Forest University Health Sciences

2 Previous Clinical Trials

432 Total Patients Enrolled

Stephen B. Kritchevsky, PhDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

In-Person Caloric Restriction Clinical Trial Eligibility Overview. Trial Name: NCT05424042 — N/A

Aging Research Study Groups: Time-Restricted Eating Arm, In-Person Caloric Restriction Arm, Remote Caloric Restriction Arm

Aging Clinical Trial 2023: In-Person Caloric Restriction Highlights & Side Effects. Trial Name: NCT05424042 — N/A

In-Person Caloric Restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05424042 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on individuals who can join this experiment?

"Confirmed. According to data posted on clinicaltrials.gov, this particular research project was initially published in July 5th 2022 and has since been updated as recently as August 2nd 2022. As of now, the program is recruiting 120 participants across a single medical centre."

Answered by AI

Are there any slots available to enroll in this experiment?

"Yes, clinicaltrials.gov confirms that the research is actively recruiting candidates. It was posted on July 5th 2022 and has been updated most recently on August 2nd 2022. This medical project aims to enroll 120 participants from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Health, Aging and Later-Life Outcomes

2022. "Health, Aging and Later-Life Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05424042.