Health, Aging and Later-Life Outcomes
- Conditions
- Aging
- Registration Number
- NCT05424042
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants That Sustained >10% Caloric Restriction Month 9 Ability of participants to sustain Caloric Restriction \>10%
Ability to Maintain Time Restricted Eating (TRE) Intervention 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 Month 9 Retention \> 85%
- Secondary Outcome Measures
Name Time Method Body Weight Change From Baseline to Month 6, and From Baseline to 9 Months Assessed using home scales.
Changes in Fat Mass From Baseline to Month 9 Assessed by (Dual-Energy X-Ray Absorptiometry) DXA.
Changes in Lean Body Mass From Baseline to Month 9 As assessed by DXA for the total lean body mass.
Change in Bone Mineral Density From Baseline to Month 9 As assessed by DXA using the Hip BMD
Change in Resting Energy Expenditure From Baseline to Month 9 As assessed by Indirect Calorimetry between baseline and 9 months follow-up
Change in Physical Activity Energy Expenditure From Baseline to Month 9 Assessed by ActivPAL
Change in Energy Intake 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
Change in Total Muscle Mass 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.
Change in Self-Reported Energy Intake 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.
Physical Function--Change in Walk Time From Baseline to Month 9 400m walk - assessed in number of seconds (unlimited time)
Physical Function--Change in Grip Strength From Baseline to Month 9 measured in kg (0-90kg)
Physical Function--Change in eSPPB 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.
Change in Cognitive Function--MoCA From baseline to Month 9 Total score ranges from 0-30 with a higher score denoting better cognitive function.
Change in Age-Related Biomarkers--Fasting Insulin From Baseline to 9 Months Fasting insulin, an age-related biomarker
Change in Age-Related Biomarkers--interleukin-6 (IL-6) From Baseline to 9 Months Interleukin-6 (IL-6) is an Age-related biomarker, cytokine, and key mediator of inflammation
Change in Age-Related Biomarkers--tumor Necrosis Factor Soluble Receptor I (TNFRI) 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.
Change in Age-Related Biomarkers--cystatin C From Baseline to 9 Months Change in cystatin C - An Age-Related Biomarker used to assess kidney function
Change in Age-Related Biomarkers-- CRP From Serum From Baseline to 9 Months Change in C-reactive Protein, an Age-Related Biomarker that is used to detect inflammation in the body
Trial Locations
- Locations (1)
Atrium Health Wake Forest Baptist Hospital
🇺🇸Winston-Salem, North Carolina, United States
Atrium Health Wake Forest Baptist Hospital🇺🇸Winston-Salem, North Carolina, United States