Reasons for Exclusion of Apparently Healthy Mature Adult and Senior Dogs From a Clinical Trial

Background: Interventional clinical trials intended to maintain health in aging dogs are unusual and require particular attention to exclusion criteria.Objectives: To describe reasons for exclusion when a mature adult and senior canine population with normal health status was sought.Animals: Fifty six companion dogs nominated for a randomized controlled trial (RCT).Procedures: Exclusions occurred within Stage 1 (S1): owner-provided survey information; Stage 2 (S2): medical records review; and Stage 3 (S3): screening examination and within Owner, Dog, or Other factor categories.Results: Of 56 nominated dogs, 39 were excluded at S1 (n = 19), S2 (n = 5), and S3 (n = 15), respectively. Dogs were excluded for Owner (n = 4), Dog (n = 27), Other (n = 6), and concurrent (Owner + Dog; n = 2) factors. The most common exclusion period was S1 (n = 19), with weight outside the target range being the most common exclusion factor in that stage (n = 10). Heart murmurs were the second most common exclusion factor (S1: n = 1; S3: n = 5); suspected or confirmed systemic illness was third most common (S1: n = 2; S2: n = 3; S3: n = 2). Among dogs who passed S1 and S2 screening (n = 32), 15 dogs (48%) were excluded at S3, for heart murmur > grade II/VI (n = 5), cardiac arrhythmias (n = 2), and clinicopathologic abnormalities (n = 2).Conclusions and Clinical Relevance: Dogs nominated for a clinical trial for healthy mature adult and senior dogs were excluded for size, previous diagnoses, and newly discovered cardiac abnormalities. For future interventions in mature adult and senior dogs of normal health status, it is important to define expected age-related abnormalities to ensure that meaningful exclusion criteria are used.

Download Full-text

Effects of daily blueberry consumption on circulating biomarkers of oxidative stress, inflammation, and antioxidant defense in postmenopausal women with pre- and stage 1-hypertension: a randomized controlled trial

Food & Function ◽

10.1039/c6fo01216g ◽

2017 ◽

Vol 8 (1) ◽

pp. 372-380 ◽

Cited By ~ 19

Author(s):

Sarah A. Johnson ◽

Rafaela G. Feresin ◽

Negin Navaei ◽

Arturo Figueroa ◽

Marcus L. Elam ◽

...

Keyword(s):

Oxidative Stress ◽

Postmenopausal Women ◽

Antioxidant Defense ◽

Controlled Trial ◽

Disease Development ◽

Circulating Biomarkers ◽

Randomized Controlled ◽

Age Related ◽

Stage 1 ◽

Biomarkers Of Oxidative Stress

Blueberries may attenuate accelerated age-related chronic disease development in postmenopausal women.

Download Full-text

Antecedent Metabolic Health and Metformin (ANTHEM) Aging study: Rationale and study design for a randomized controlled trial.

10.1101/2021.10.20.21265196 ◽

2021 ◽

Author(s):

Santosh Kumari ◽

Matthew Bubak ◽

Hayden M. Schoenberg ◽

Arik Davidyan ◽

Christian J. Elliehausen ◽

...

Keyword(s):

Skeletal Muscle ◽

Clinical Trial ◽

Insulin Sensitivity ◽

Controlled Trial ◽

Metabolic Health ◽

Metformin Treatment ◽

Insulin Resistant ◽

Age Related ◽

And Function ◽

Mitochondrial Remodeling

The antidiabetic medication metformin has been proposed to be the first drug tested to target aging and extend healthspan in humans. While there is extensive epidemiological support for the health benefits of metformin in patient populations, it is not clear if these protective effects apply to those free of age-related disease. Our previous data in older adults without diabetes suggest a dichotomous change in insulin sensitivity and skeletal muscle mitochondrial adaptations after metformin treatment when co-prescribed with exercise. Those who entered the study as insulin sensitive had no change to detrimental effects while those who were insulin resistant had positive changes. The objective of this clinical trial is to determine if 1) antecedent metabolic health and 2) skeletal muscle mitochondrial remodeling and function mediate the positive or detrimental effects of metformin monotherapy, independent of exercise, on the metabolism and biology of aging. In a randomized, double blind clinical trial, adults free of chronic disease (n=148, 40-75 years old) are stratified as either insulin sensitive or insulin resistant based on HOMA-IR (≤2.2 or ≥2.5) and take 1500 mg/day of metformin or placebo for 12 weeks. Hyperinsulinemic-euglycemic clamps and skeletal muscle biopsies are performed before and after 12 weeks to assess primary outcomes of peripheral insulin sensitivity and mitochondrial remodeling and function. Findings from this trial will identify clinical characteristics and cellular mechanisms involved in modulating the effectiveness of metformin treatment to target aging that could inform larger phase 3 clinical trials aimed at testing aging as an indication for metformin.

Download Full-text

Antecedent Metabolic Health and Metformin (ANTHEM) Aging study: Rationale and study design for a randomized controlled trial

The Journals of Gerontology Series A ◽

10.1093/gerona/glab358 ◽

2021 ◽

Author(s):

Santosh Kumari ◽

Matthew Bubak ◽

Hayden M Schoenberg ◽

Arik Davidyan ◽

Christian J Elliehausen ◽

...

Keyword(s):

Skeletal Muscle ◽

Clinical Trial ◽

Insulin Sensitivity ◽

Controlled Trial ◽

Metabolic Health ◽

Metformin Treatment ◽

Double Blind ◽

Age Related ◽

And Function ◽

Mitochondrial Remodeling

Abstract The antidiabetic medication metformin has been proposed to be the first drug tested to target aging and extend healthspan in humans. While there is extensive epidemiological support for the health benefits of metformin in patient populations, it is not clear if these protective effects apply to those free of age-related disease. Our previous data in older adults without diabetes suggest a dichotomous change in insulin sensitivity and skeletal muscle mitochondrial adaptations after metformin treatment when co-prescribed with exercise. Those who entered the study as insulin sensitive had no change to detrimental effects while those who were insulin resistant had positive changes. The objective of this clinical trial is to determine if 1) antecedent metabolic health and 2) skeletal muscle mitochondrial remodeling and function mediate the positive or detrimental effects of metformin monotherapy, independent of exercise, on the metabolism and biology of aging. In a randomized, double blind clinical trial, adults free of chronic disease (n=148, 40-75 years old) are stratified as either insulin sensitive or resistant based on HOMA-IR (≤2.2 or ≥2.5) and take 1500 mg/day of metformin or placebo for 12 weeks. Hyperinsulinemic-euglycemic clamps and skeletal muscle biopsies are performed before and after 12 weeks to assess primary outcomes of peripheral insulin sensitivity and mitochondrial remodeling and function. Findings from this trial will identify clinical characteristics and cellular mechanisms involved in modulating the effectiveness of metformin treatment to target aging that could inform larger phase 3 clinical trials aimed at testing aging as a treatment indication for metformin.

Download Full-text

Facebook Is a Useful Recruitment Strategy for a Randomized Clinical Trial of a Lifestyle Approach to Reverse Metabolic Syndrome

Current Developments in Nutrition ◽

10.1093/cdn/nzaa056_020 ◽

2020 ◽

Vol 4 (Supplement_2) ◽

pp. 1173-1173

Author(s):

Barbara Lohse ◽

Kathryn Faulring ◽

Claire Cook

Keyword(s):

Metabolic Syndrome ◽

Clinical Trial ◽

Controlled Trial ◽

Cost Effective ◽

Recruitment Strategy ◽

Exclusion Criteria ◽

Funding Sources ◽

Contact Information ◽

Co Morbidity ◽

Telephone Screening

Abstract Objectives Design and evaluate a Facebook (FB) campaign to recruit a select sample with metabolic syndrome (MetS) to participate in a telephone screening for inclusion in a randomized controlled trial of the efficacy of a lifestyle medicine intervention to reverse MetS. Methods Inclusion and exclusion criteria for participation in the Enhanced Lifestyles for Metabolic Syndrome (ELM) study informed development of a FB ad, utilizing FB guidelines. After clicking a FB ad, co-morbidity and contact information to schedule a screening call were captured via survey using a Qualtrics platform. Phone screen eligibility was defined as having no listed co-morbidities. Providing contact information in addition was deemed to be complete and phone screen-ready. Phone screen eligibility and readiness frequencies were compared to FB campaign performance data on reach, link clicks, demographics and costing using the Checklist for Reporting Results of Internet E-Surveys (CHERRIES) system. Participation was not incentivized. Results The 14-day FB campaign, driven by 11 phrases pertinent to MetS, had a potential reach of 690,000 with ad impressions on 33,243 unique FB accounts resulting in 1160 ad clicks. Ad impressions appeared mostly in female accounts; 90% of ad clickers were female from 18 to 65y or higher; the majority were >45y. Costs ranged from $.47 to $.83/click (averaged $0.61). Total campaign costs were $708.57. Of the 1160 ad clicks, 422 moved past survey page 1, 114 were eligible for phone screening and 85 were phone screen-ready. Of the 85 that provided contact details, 51 completed the phone screen and 21 were deemed eligible for the ELM baseline assessment. CHERRIES response rates were: View 3.5%; Survey participation 36.4%; Phone screen eligible 27% and Completion 74.6%. Of those who clicked on the ad, 7.3% were Phone screen-ready and 20.1% starting the survey were Phone screen-ready. Costs were $6.216 to recruit a phone screen eligible person; $8.336/phone screen-ready person; $13.894/phone screen completion and $33.741/ELM baseline screen eligible subject. Personnel time was <4 h for the FB campaign. Conclusions FB was a cost-effective strategy, requiring minimal personnel investment, to recruit subjects to a MetS clinical trial with demanding inclusion/exclusion criteria. Funding Sources William G. McGowan Charitable Fund, Wegmans School of Health & Nutrition, RIT.

Download Full-text