Aging Clinical Trial
— HALLO-POfficial 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
Verified date | April 2024 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Atrium Health Wake Forest Baptist Hospital | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of sustained CR | CR > 10% | Month 9 | |
Primary | TRE sustainability | At least 75% of participants eating within window on >80% of days | Month 9 | |
Primary | Retention of study participants | Retention > 85% | Month 9 | |
Secondary | Body Weight Change | Assessed using home scales. | From Baseline to Month 6, and From Baseline to 9 Months | |
Secondary | Changes in Fat | Assessed by (Dual-Energy X-Ray Absorptiometry) DXA. | From Baseline to Month 9 | |
Secondary | Changes in Lean Body Mass | Assessed by DXA | From Baseline to Month 9 | |
Secondary | Change in Bone Mineral Density | Assessed by DXA | From Baseline to Month 9 | |
Secondary | Change in Resting Energy Expenditure | Assessed by Indirect Calorimetry | From Baseline to Month 9 | |
Secondary | Change in Physical Activity Energy Expenditure | Assessed by ActivPAL | From Baseline to Month 9 | |
Secondary | 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 | From Baseline to Month 9 | |
Secondary | Change in Total Muscle Mass | Assessed by d3 creatine (d3cr) | From Baseline to Month 9 | |
Secondary | 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. | From Baseline to Month 9 | |
Secondary | Physical Function--Change in Walk Time | 400m walk - assessed in minutes/secs (unlimited time) | From Baseline to Month 9 | |
Secondary | Physical Function--Change in Grip Strength | measured in kg (0-90kg) | From Baseline to Month 9 | |
Secondary | Physical Function--Change in eSPPB | Change in overall physical performance with total score ranging from 0 to 12 with a higher score denoting better physical function. | From Baseline to Month 9 | |
Secondary | Change in Cognitive Function--MoCA | Total score ranges from 0-30 with a higher score denoting better cognitive function. | From baseline to Month 9 | |
Secondary | Change in Age-Related Biomarkers--Fasting Insulin | From Baseline to 9 Months | ||
Secondary | Change in Age-Related Biomarkers--interleukin-6 (IL-6) | From Baseline to 9 Months | ||
Secondary | Change in Age-Related Biomarkers--tumor necrosis factor soluble receptor I (TNFRI) | From Baseline to 9 Months | ||
Secondary | Change in Age-Related Biomarkers--cystatin C | and CRP from serum | From Baseline to 9 Months | |
Secondary | Change in Age-Related Biomarkers-- CRP from serum | From Baseline to 9 Months |
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