Objective: This study examined the association between 5-aminolevulinic acid (5-ALA) and glucose tolerance. Design: A double blinded, randomized prospective parallel-group comparison study. Setting: Participants were recruited from the community in Honolulu, Hawaii, using radio and TV ads, and at community events. Participants: One hundred fi fty-four males and females ages 40-70 years, with evidence of prediabetes: hemoglobin A1c (HbA1c) 5.8%-7.0% at the screening visit. Intervention: Participants were randomized equally to one of three study groups: (1) low dose 5-ALA supplement (15 mg capsule); (2) high dose 5-ALA (50 mg capsule); and (3) control (placebo capsule of identical size and color). Main outcome measures: HbA1c and 2 hours post-oral glucose tolerance test (OGTT) glucose levels. Results: Among individuals taking 5-ALA supplements for 12 weeks, 2 hours post-OGTT glucose levels declined signifi cantly compared to those not taking the supplement ( p = 0.02). The relationships were stronger among those with baseline glucose intolerance, or 2 hours post-OGTT glucose measurements greater than 140 mg/dL ( p = 0.005 and p = 0.02 for the low and high dose group, respectively). Similar trends were observed for HbA1c but results were of borderline signifi cance ( p = 0.07). No untoward effects were reported. Conclusions: Further studies are indicated. The potential benefi ts of 5-ALA dietary supplementation are affi rmed by this investigation.
Problem: 5-ALA has been used for many years at relatively high dose amounts in single doses for photodynamic therapy and immunofluorescence of tumors. An analysis of compiled data relating to safety and any side-effects about the use of 5-ALA at low doses has not yet been published. Purpose: This report analyzes data about the safety of the use of 5-Aminolevulinic Acid (5-ALA) in low doses as a supplement over an extended period of time. Methods: This investigation is a systematic analysis of the current literature ((Medline, and SBI) and snowballing techniques) related to the safety and efficacy of 5-ALA in animals and humans. Clinical trials in progress using 5-ALA were also analyzed. Constant comparative analyses were used to synthesize the findings. Results: The safety of low-dose 5-ALA as a supplement has been demonstrated by animal and human studies. The results suggest that none of the investigations document the presence of symptoms or abnormal laboratory results of clinical significance. The minor laboratory changes documented were judged not clinically significant.
Background We evaluated the perceived success of recruitment and retention protocols for Native Hawaiian/Pacific Islander/Filipino populations. These three groups were found to have a significantly higher incidence of health disparities than the general population. Training applications of selected vignettes were also generated. Methods Focus groups and questionnaires were used to achieve the objective: Identification of themes related to facilitators and deterrents to participation in clinical trials in these populations. This mixed methods approach evaluated promotional materials preferred. Responses to animated videos and vignettes with actors regarding clinical research participation were analyzed. Participants included adults of Hawaiian/Pacific Islander or Filipino ethnicity. Analysis included grounded theory methods, such as constant comparative techniques. Results The results revealed that attention to the following categories is essential: culturally sensitive knowledge, attitudes, and beliefs related to individuals, families and communities. Discussion These themes are recommended as the structure for future interventions to improve participation and retention within these groups.
Objective: To determine if there is a relationship between the administration of the dietary supplement containing 5-Aminolevulinic Acid (5-ALA) and sleep. Methods: A double-blind, randomized parallel-group study was conducted. It was a 4-month study of 40 participants between the ages of 40 and 70. Males and females were recruited equally. There were 20 in each group who had existing sleep disorders. The tool used to measure participant sleep improvement included the Pittsburgh Insomnia Rating Scale-20 Question (PIRS-20). Improved sleep is reflected when the total PIRS-20 score is lower. Results: Improvement in sleep in the group taking 50 mg 5-ALA, compared to controls, was significant. The mean change, from baseline through week 6, was −5.67 units less on the sleep scale than the control group with a p value of 0.001. The mean change from week 6 to week 10 when the participant was no longer taking the supplement was 4.55 units higher than the control group with a p value of 0.062, which is of borderline significance. Conclusions: There is a relationship between the administration of dietary supplements containing 5-ALA and sleep. The results of this study suggest that 5-ALA is associated with improved sleep. The mechanism for sleep improvement needs to be explored. Further research is warranted.
In 2010, approximately 79 million Americans had prediabetes and about 50 percent of those individuals were 65 years and older. The most effective diabetes prevention method in prediabetic adults is lifestyle modification. However, despite the benefits of lifestyle change, diabetes prevalence continues to increase. Maintaining a regular exercise routine and a healthy eating plan may be difficult because of the negative emotional barriers (i.e., stress, mood) that a prediabetic individual faces. This is particularly evident in older individuals when you combine that with decreases in mobility and geriatric syndromes. A potential treatment for these emotional barriers is a natural supplement called 5-aminolevulinic acid (5-ALA). In the current study, the group included 154 participants, both men and women, ranging between the ages of 41 to 71 years old. The study design was a double-blind, randomized parallel-group study. The Psychosocial Depressive Symptoms Questionnaire (PDS) and the Perceived Stress Scale (PSS) were used to examine the effect of two doses of 5-ALA (15 mg and 50 mg) on various components of mood (i.e., hopefulness, loneliness, and motivation) and coping ability. Using SAS software, an ordered logistic regression model was used to analyze the association between the dose groups (control, 15 mg, and 50 mg) and the responses to the two questionnaires, the PDS and PSS, used in this study. An integrative literature review, using the PubMed database, searched for studies on the relationship between 5-ALA administration and mood and coping ability. Our literature review resulted in zero published articles. Next, we found that the intake of 5-ALA was significantly associated with improved coping ability (p = 0.004) and improved self-perception of effort spent (p = 0.002). Finally, we found a significant dose-dependent relationship for the association of 5-ALA intake on measures of effort (p = 0.003), loneliness (p = 0.006), and coping ability (p = 0.003). The 50 mg dose was more effective than the 15 mg dose in improving these measures. In conclusion, after 12 weeks of taking 5-ALA, we found significant improvements in self-perception of effort spent, loneliness, and coping ability in prediabetic middle age and older adults. Improved mood and coping ability may allow prediabetic individuals to overcome the emotional obstacles preventing them from maintaining a healthy lifestyle and ultimately, help them to avoid the development of diabetes.
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