N/A
N=90
Health, Aging and Later-Life Outcomes
Aging
Bottom Line
View on ClinicalTrials.gov: NCT05424042 ↗Enrolled (actual)
90
Serious AEs
5.6%
Results posted
Oct 2025
Primary outcome: Primary: Number of Participants That Sustained >10% Caloric Restriction — 7; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- In-Person Caloric Restriction (Behavioral); Remote Caloric Restriction (Behavioral); Time-restricted (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Sustained >10% Caloric Restriction |
7; 12 | — |
| PRIMARY Ability to Maintain Time Restricted Eating (TRE) Intervention |
83.5 | — |
| PRIMARY Number of Participants Who Were Retained |
20; 34; 29 | — |
| SECONDARY Body Weight Change |
-4.47; -6.09; -1.35; -4.44; -6.66; -0.94 | — |
| SECONDARY Changes in Fat Mass |
-2.92; -4.46; 0.02 | — |
| SECONDARY Changes in Lean Body Mass |
-1.73; -2.21; -0.59 | — |
| SECONDARY Change in Bone Mineral Density |
-0.01; -0.01; -0.00 | — |
| SECONDARY Change in Resting Energy Expenditure |
-35.3; -74.1; -94.8 | — |
| SECONDARY Change in Physical Activity Energy Expenditure |
0.42; 0.68; 0.29 | — |
| SECONDARY Change in Energy Intake |
-129.5; -133.6; -45.6 | — |
| SECONDARY Change in Total Muscle Mass |
-1.46; 0.64; 1.88 | — |
| SECONDARY Change in Self-Reported Energy Intake |
-371.4; -244.1; -255.6 | — |
| SECONDARY Physical Function--Change in Walk Time |
-7.05; -19.76; -19.18 | — |
| SECONDARY Physical Function--Change in Grip Strength |
-1.47; -0.48; -0.38 | — |
| SECONDARY Physical Function--Change in eSPPB |
-0.10; 0.08; -0.00 | — |
| SECONDARY Change in Cognitive Function--MoCA |
1.20; 0.68; 1.17 | — |
| SECONDARY Change in Age-Related Biomarkers--Fasting Insulin |
-5.60; -12.41; -2.06 | — |
| SECONDARY Change in Age-Related Biomarkers--interleukin-6 (IL-6) |
1.20; -0.22; 0.30 | — |
| SECONDARY Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI) |
-3.80; -55.12; -15.52 | — |
| SECONDARY Change in Age-Related Biomarkers--cystatin C |
-0.10; -0.04; -0.24 | — |
| SECONDARY Change in Age-Related Biomarkers-- CRP From Serum |
1.12; 0.60; 1.20 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05424042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.