• 제목/요약/키워드: Placebo-controlled study

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The Effects of Combination of Functional Beverage(Garcinia Cambogia, L-Carnitine, and Soy Peptide) and Exercise on the Improvement of Body Fat

  • Kim, Kyung-Soo;Jung, Ju-Hae;Song, Chan-Hee;Sung, Bong-Ju
    • Biomolecules & Therapeutics
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    • 제11권2호
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    • pp.99-108
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    • 2003
  • Background: There is abundance of studies on the decrease in body fat through limited calorie intake or exercise; however, studies focusing simultaneously on functional foods and exercise are rare. This study was aimed to identify the effects of combination of a functional beverage and exercise on body composition and biochemical metabolic profiles. Method: Eighty-one healthy volunteers (69 females aged 19 to 50 years and 12 males aged 19 to 55 years), who maintained their body weight stable with 23 or higher in BMI (kg/$m^2$) and 25% or higher body fat for the last three months, were recruited in the study through written advertisement. All the subjects gave their informed consent, and the study was conducted in accordance with the Declaration of Helsinki. The study design was a randomized double-blind placebo-controlled parallel group design. All participants were given 12-week programed-exercise, which was performed 3 times a week. One bottle (100 ml) of test (Garcinia cambogia 300 mg, L-carnitine 20 mg, Soy peptide 1,000 mg) or placebo solution was given daily 30 min before each session of programed-exercise. BMI (body mass index), %fat, local fat amount (visceral and mid-thigh), waist circumference, skin fold thickness and some biochemical metabolic parameters like glucose, insulin and free fatty acids, etc in the blood were measured and compared before and after 12-week intervention within groups as well as between groups according to the protocol Results: Twenty six volunteers were dropped out and fifty five volunteers completed the study. At the end of 4, 8, and 12 weeks, approximately 1.98%, 3.00% and 3.50% losses of initial body weight were observed, respectively, in the test group (P<0.01), and 0.29, % ,0.74%, 1.60%, respectively, in the placebo group (P>0.05). BMI changed by 2.40%, 3.41% and 4.46%, respectively, in the test group, and 0.38%, 0.95% and 1.75%, respectively, in the placebo group, at each period of time. The reductions of body weight and BMI were significantly higher in the test group than in the placebo group at each period of time (P<0.05). Conclusions: It is thought that the combination of functional beverage, which contains mostly garcinia cambogia, L-carnitine, and soy peptide, and exercise have synergy effects on reducing body fat.

헬리코박터 필로리 양성 만성위염환자에서 제균약제 및 고려 홍삼정 (정관장) 투여에 따른 치료효과 이중 맹검, 위약비교 연구 (The efficacy of eradication therapy and Korea Red Ginseng administration on Helocobacter pylori-associated chronic gastritis double blind, placebo controlled study)

  • 여말희;이정아;김동규;박희진;정재용;김영배;이기명;이광재;김진홍
    • 고려인삼학회:학술대회논문집
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    • 고려인삼학회 2005년도 춘계 학술대회 및 총회
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    • pp.8-11
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    • 2005
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Effects of 8 weeks administration of Korean Panax ginseng extract on the mood and cognitive performance of healthy individuals

  • L., Reay J.;B., Scholey A.;O., Kennedy D.
    • Journal of Ginseng Research
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    • 제31권1호
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    • pp.34-43
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    • 2007
  • Background: Previous research has suggested that single doses of a standardised Panax ginseng extract can decrease fasted blood-glucose levels and modulate cognitive performance in healthy young volunteers. The latter has generally been seen in terms of improved secondary memory performance. However, both the cognitive effects of chronic administration of ginseng and the potential modulation of working memory have received comparatively little research attention. Aims: The current double-blind, placebo-controlled, balanced cross-over study investigated the effects of 8-weeks administration of Korean ginseng extract (200 mg) on cognitive performance, gluco-regulatory parameters and ratings of subjective mood and 'quality of life'. Methods: 'Eighteen healthy young participants were assessed pre-dose and 3 hours post-dose on the mornings of Day 1, Day 29 and Day 57 of 8 week treatment regimens of both placebo and ginseng. A four-week placebo wash-out separated the treatment phases. Each assessment included the Cognitive Drug Research battery, computerised working memory tasks, and Bond-Lader mood scales. The WHO Quality of Life scale (WHOQOL-BREF) was completed once per visit. Gluco-regulatory parameters were assessed with assays of blood glucose, insulin and HbA1c. Results: Data from the 16 participants that completed the study showed that there were no significant, acute treatment related differences on Day 1 of treatment, or in gluco-regulatory parameters throughout the study. However, time related performance improvements were evident following chronic administration of ginseng on the '3-Back' and 'Corsi-block' computerised working memory tasks. Ginseng was also associated with an improved score on the 'social relations' subscale of the WHOQOL-100, and a significant shift on the 'calm' factor of the Bond-Lader mood scales (from calm/relaxed towards excited/tense). Conclusion: The results of the current study suggest that Korean ginseng extract can modulate working memory performance and subjective ratings of 'quality of life' and mood. Replication with a larger sample size may further elucidate the actions of this product.

자기를 이용한 경락 자극요법 시행 후 요부근육통 환자의 체열변화 관찰: 무작위배정, 환자-평가자 눈가림, 위기기 대조군, 예비 임상 연구 (Observation on Change of Body Temperature for Patients with Low Back Muscular Pain after Electromagnetic Theraphy: a Randomized, Patient-assessor Blind, Placebo-controlled, Pilot Trial Study)

  • 조웅희;박원형;차윤엽;선승호;이선구
    • 한방재활의학과학회지
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    • 제21권4호
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    • pp.145-156
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    • 2011
  • Objectives: This study was resigned to observe change of body temperature for patients with low back muscular pain after NUGA MRT-II(pulsed electromagnetic therapy) treatment. Methods: This study was a randomized, patient-assessor blind, placebo-controlled, pilot trial study. After the approval of institutional review board(IRB), we have recruited 38 patients suffering from low back muscular pain and divided them into two groups randomly: the treatment group and control group. To the treatment group, NUGA MRT-II was practiced and to the control group sham device was practiced and their low back muscles and acupuncture points three times a week for 2 weeks from February 2011 to May 2011. After 1 week of last treatment, We compared body temperature of two groups. Results: 1. There was significant decrease of body temperature on both Shinsu(BL23), Chishil(BL52), Kwanwonsu(BL26) acupunture points for the treatment group. 2. There was no difference in the decrease of body temperature between treatment group and control group except. Left Kwanwonsu(BL26). Conclusions: We found out that treatment of NUGA MRT-II on low back muscular pain can reduce the temperature of low back.

The Combined Effect of Caffeine and Ornithine on the Mood of Healthy Office Workers

  • Misaizu, Akane;Kokubo, Takeshi;Tazumi, Kyoko;Kanayama, Masaya;Miura, Yutaka
    • Preventive Nutrition and Food Science
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    • 제19권4호
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    • pp.367-372
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    • 2014
  • Caffeine is widely consumed and well known for stimulating the central nervous system. When developing new foods and beverages that contain caffeine, it is important to explore the potential synergistic effects of consuming amino acids and other food ingredients with caffeine on humans. Given the physiological pathways affected by the amino acid ornithine, consumption of ornithine with caffeine may have synergistic effects. The purpose of the present study was to examine the effect of consuming caffeine with ornithine in humans. The study used a randomized, placebo-controlled, double-blinded crossover design. The subjects were all healthy office workers who ingested the placebo, 100 mg caffeine, or 100 mg caffeine plus 200 mg ornithine in the morning and completed questionnaires about their mood. Office workers who consumed the combination of caffeine and ornithine had higher mood ratings 8 h after consumption than office workers who consumed caffeine alone. The results of the present study suggest that there is a unique synergistic effect between caffeine and ornithine on the mood of healthy office workers and that ornithine may potentiate the effects of caffeine.

The fruit of Acanthopanax senticosus Harms improves arterial stiffness and blood pressure: a randomized, placebo-controlled trial

  • Oh, Eunkyoung;Kim, Youjin;Park, Soo-yeon;Lim, Yeni;Shin, Ji-yoon;Kim, Ji Yeon;Kim, Ji-Hyun;Rhee, Moo-Yong;Kwon, Oran
    • Nutrition Research and Practice
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    • 제14권4호
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    • pp.322-333
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    • 2020
  • BACKGROUND/OBJECTIVES: Arterial stiffness and endothelial dysfunction are 2 of the independent predictors for cardiovascular disease, while Acanthopanax senticosus Harms (ASH) is a traditional medicinal plant that can improve cardiovascular health. This study aimed to investigate the efficacy of the fruit of ASH on vascular function in apparently healthy subjects. SUBJECTS/METHODS: A 12-week, randomized, double-blind, placebo-controlled design, consisting of healthy adults with at least 2 of the following 3 conditions: borderline high blood pressure (BP; 120 mmHg ≤ systolic BP ≤ 160 mmHg or 80 mmHg ≤ diastolic BP ≤ 100 mmHg), smoking (≥10 cigarettes/day), and borderline blood lipid levels (220 ≤ total cholesterol ≤ 240, 130 ≤ low density lipoprotein cholesterol ≤ 165, or 150 ≤ triglyceride ≤ 220 mg/dL). Randomly assigned 76 subjects who received a placebo or 2 doses of ASH fruit (low, 500 mg/day; high, 1,000 mg/day) completed the intervention. Brachial-ankle pulse wave velocity (baPWV), flow-mediated dilation, carotid intima-media thickness, and BP were measured both at baseline and following the 12-week intervention. Endothelial nitric oxide synthase (eNOS) phosphorylation was assessed by western blotting. RESULTS: Compared with the placebo group, the low-dose group showed more significant changes after the 12-week intervention period in terms of systolic BP (0.1 vs. -7.7 mmHg; P = 0.044), baPWV (31.3 vs. -98.7 cm/s; P = 0.007), and the ratio of phospho-eNOS/eNOS (0.8 vs. 1.22; P = 0.037). CONCLUSIONS: These results suggest that ASH fruit extract at 500 mg/day has the potential to improve BP and arterial stiffness via endothelial eNOS activation in healthy adults with smoking and the tendency of having elevated BP or blood lipid parameters.

슈퍼홍미 미강 추출물의 폐경 후 여성의 혈중 지질 농도 및 대사성 질환 개선 효과 (Superhongmi bran extract improves lipid profile and menopause symptoms: a randomized, placebo-controlled clinical trial)

  • 정수임;남수진;;;강미영
    • 한국식품과학회지
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    • 제51권2호
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    • pp.182-187
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    • 2019
  • 본 연구는 슈퍼홍미 미강 추출물이 폐경 후 갱년기 증상에 및 대사 개선 효과를 확인하고자 수행되었다. 무월경이 지속된 지 5년 미만의 여성을 대상으로 12주동안 진행되었으며 위약대조군 15명, 실험군 15명으로 배정하였고, 1일 2개의 캡슐을 섭취하도록 하였다(슈퍼홍미 미강추출물 700 mg/day). 시험 종료 후 슈퍼홍미 미강 추출물 섭취군의 체중과 BMI 그리고 중성지질과 및 총콜레스테롤은 수준이 유의하게 감소하였다. 혈중 HDL 콜레스테롤과 ApoA1 농도는 약 10% 증가하여 지질대사 개선에 효과를 기대할 수 있었다. 항당뇨과 관련된 지표 중 혈중 glucose와 인슐린이 유의하게 감소하여 인슐린 저항성 지표인 HOMA-IR이 감소한 것을 확인할 수 있었고, 아디포넥틴 수준이 유의하게 증가하였으며, $TNF-{\alpha}$는 슈퍼홍미 미강 추출물 섭취군에서 투여 전보다 유의하게 감소하여 폐경 이후 당질대사 개선에 도움을 줄 수 있을 것으로 보인다. 항산화활성 분석 결과 SOD1, GSH 그리고 TBARS 수준이 실험군에서 감소하였으며, AOPP 는 유의적인 차이를 보이지 않았다. 여성호르몬 중 $17{\beta}-estradiol$과 progesterone 농도는 위약대조군에서 유의하게 감소하였으나 실험군은 섭취기간동안 호로몬 농도를 유지한 것으로 나타나 대조군에 비해 높은 수준을 나타났다. 폐경을 겪은 여성들은 여성호르몬 저하로 인해 갱년기 증상 및 대사증후군 발병 가능성이 증가하는데 슈퍼홍미 미강과 같은 기능성 식품 섭취로 대사증후군 위험인자들에 대한 호전이 높을 것이라 보고 이러한 연구 결과는 갱년기 여성 건강에 시사하는 바가 크다고 생각된다.

침 임상시험 논문에 적용한 Sham Acupuncture에 대한 고찰 (The Study of the Sham Acupuncture for Acupuncture Clinical Trials)

  • 정찬영;장민기;조재용;김은정;박인식;김갑성
    • Journal of Acupuncture Research
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    • 제25권6호
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    • pp.77-93
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    • 2008
  • Objectives : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group or use another therapy for control group. So, we didn't say it was true acupuncture effect, though subjects in clinical study improved. Recently several sham needles for control group were developed and validated. This study aimed at summarizing the validation studies of these needles and evaluating the control group of the acupuncture clinical study. Methods : Computerized literature searches were performed using 'acupuncture' and 'placebo or sham' with a limitation of the results to RCTs in Pubmed, Sciencedirect, NDSL, KISS, RISS. Data were extracted regarding study design, sample size, acupuncture point, stimulation form, credibility testing. And We have examined 106 acupuncture clinical studies published by Pubmed from January 1, 2005 to April 30, 2008. Data were extracted author's country, subject of study, type of study groups, type of control groups, type of blinding, difference between the results in the control groups. Results : Streitberger's placebo needle, Fink's sham needle, Park sham needle, Kim sham needle were developed. They were validated at domestic and abroad. But the results were deviation depending on the each of the researcher. They has shown that sample, acupuncture points, experiences or knowledge of acupuncture dependent on the results. Recent three years, acupuncture clinical trial had different results. Significant differences between Study group and control group emerged from using other therapy or non-treatment for control group. Many study has no significant differences using sham acupuncture for control groups. Conclusions : Acupuncture clinical studies need to meet several requirements. First of all, they require the basics of randomized controlled clinical studies such as blinding and the accurate implementation and description of randomization. And also need to research the unique circumstances of these studies such as the development of sham acupuncture and blinding method which differs from other clinical trials.

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