A combination of various functional food ingredients as a weight management program: randomized, placebo-controlled, and double-blind human clinical studies

2011 ◽  
Vol 1 (12) ◽  
pp. 555 ◽  
Author(s):  
Harunobu Amagase

Background: Lycium barbarum increased the postprandial energy expenditure (PPEE). Negative energy balance caused by the systematic procedure (TAIslim® System), including increasing metabolic rate through physical activity, use of Lycium barbarum-containing TAIslim (Product A), and decreasing caloric intake by consuming a chewable confection (TAIslim SKINNY=Product B), and a meal replacement shake (TAIslim SHAKE=Product C), would be successful for weight loss.Methods: We examined TAIslim System on anthropometrics, appetite in Study 1 and PPEE in Study 2, both in a randomized, placebo-controlled, double-blind manner. 1) A total of 67 participants were randomized into 2 groups (placebo or TAIslim System). Intake procedures were: Product A, 60 ml (20 kcal) b.i.d. immediately before breakfast and lunch, Product B, 1 chew (20 kcal) t.i.d. between meals and after dinner; Product C, 40.5 g (158 kcal) as breakfast. A calorie-restricted diet with multi-vitamin supplementation and daily exercise was required. Anthropometric parameters were assessed at baseline, 4, 8, and 12 w. 2) Appetite was measured using a subjective visual analog scale during the initial 3-7 days of intake. 3) For PPEE evaluation, 12 participants consumed a single bout of TAIslim System products or placebo, and took part in 6 study sessions. EE was measured by an indirect calorimeter immediately before (baseline) and at 1, 2, and 4 h post-intake of samples.Results: 1) Body weight was significantly reduced by 6.2±0.7%, compared to pre-intervention with TAIslim System (P<0.01). Waist circumference, total body fat, blood pressure, and fasting blood glucose levels were also significantly reduced by TAIslim System, in a range of 3.8-9.9%. TAIslim System was significantly more effective than the placebo (P<0.05). The placebo group showed -0.1-3.9% reduction from pre-intervention with no significant difference. 2) TAIslim System also significantly suppressed appetite, by 39%, compared to the baseline and placebo (P<0.05) (11% reduction in the placebo). 3) PPEE was significantly increased by TAIslim System compared to placebo and baseline levels. Compared to the baseline EE, placebo increased only by 0.8±0.9%, but 7.2±1.2 % with TAIslim System (P<0.01).Conclusions: It is suggested that TAIslim System exhibits significant weight loss and stimulating effects on caloric expenditure, and thus may be a useful and effective weight loss program.Keywords: Lycium barbarum, Goji, Fiber, Phenylalanine, N-Acetyl-L-Tyrosine, Tea, Polyphenols, Human clinical trial, Energy expenditure, Resting metabolic rate, Waist circumference, Appetite, Body mass index, TAIslim.

1987 ◽  
Vol 73 (1) ◽  
pp. 41-45 ◽  
Author(s):  
P. Leslie ◽  
R. T. Jung ◽  
T. E. Isles ◽  
J. Baty

1. In the management of the non-insulin dependent diabetic patient, metformin often facilitates weight loss whereas sulphonylurea may predispose to weight gain. To investigate whether this is due to alterations in energy expenditure we have studied energy expenditure in seven non-insulin dependent diabetic subjects while on metformin or sulphonylurea therapy. 2. Three components of energy expenditure were measured by indirect calorimetry, namely resting metabolic rate and the thermic responses to infused noradrenaline and to a mixed constituent meal. 3. There was no significant difference in the resting metabolic rate on metformin (5.29 ± 0.41 kJ/min; mean ± se) compared with sulphonylurea (5.34 ± 0.34 kJ/min). The resting metabolic rate was also similar to predicted values for non-diabetic subjects (r = 0.96). 4. The thermic response to infused noradrenaline was similar on metformin (23.14 ± 1.87 kJ) and sulphonylurea (21.40 ± 2.98 kJ). 5. There was no significant difference in the thermic response to the meal on sulphonylurea (75.8 ± 7.5 kJ) or on metformin (86.8 ± 10.8 kJ; 95% confidence limits − 17 to + 39 kJ). 6. We conclude that in non-insulin dependent diabetic subjects metformin does not enhance energy expenditure overall, compared with sulphonylurea.


2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Fathimath Naseer ◽  
Ruth Price ◽  
Adele McElroy ◽  
Carel Le Roux ◽  
Tamsyn Redpath ◽  
...  

AbstractBariatric surgery, including Gastric Bypass (GBP) Surgery, is the most efficient modality to manage severe obesity. Resting Energy Expenditure (REE) is an area of interest in the context of weight loss (WL) as it has been postulated to be an independent predictor of WL success following GBP. As such, the aim of this study is to investigate the impact of REE on WL following GBP. 31 GBP patients (77.4% females BMI 45.5 ± 7.0kg/m2 ; 47.3 ± 11.6y) and 32 weight-stable controls (46.9% females; BMI 27.0 ± 4.6kg/m2 ; 41.1 ± 13.5y) were assessed at one-month pre-surgery and at 3 and 12-months post-surgery. Fat mass (FM) and fat-free mass (FFM) were measured using dual energy X-ray absorptiometry (Lunar iDXA, GE Healthcare). REE was measured under standardised conditions using indirect calorimetry (ECAL, Metabolic Health Solutions). Statistical analyses were performed with SPSS v24.0, Armonk, NY. Multiple regression analysis showed that FM (P = 0.001), FFM (P < 0.0001) and gender (P = 0.012) significantly predicted the interindividual variability in REE. Total body weight (TBW) was removed from the model due to collinearity. Adjusted-REE values were then generated using the above predictor variables. Low-REE and high-REE groups were created using within-group adjusted-REE split. At both follow-ups (3- and 12-months post-surgery), patients had a greater reduction in TBW, FM, FFM, measured-REE and adjusted-REE values compared with controls (P < 0.0001). There was also no significant difference between measured and adjusted-REE values at all time-points (P > 0.05). Patients with high REEs at baseline lost more TBW than those in the low-REE group at 3-months post-surgery (-24.9 ± 6.5 kg vs. -16.6 ± 7.0 kg; P = 0.005) and 12-months post-surgery (-41.3 ± 12.5 kg vs. -25.8 ± 10.4.0 kg; P = 0.003). There was no significant difference in mean TBW changes for controls in the low-and high-REE groups at both follow-ups. Patients with high REEs at 3-months post-surgery did not lose more TBW than those in the low-REE group at 12-months post-surgery (-30.1 ± 12.8 kg vs. -38.6 ± 14.4 kg; P = 0.155). Similarly, there was no difference in mean TBW reduction between controls in the low- and high-REE groups (P = 0.115). Thus while patients with a high adjusted-REE value at baseline (> 9746.6kJ/day) lost more weight at 3- and 12-months post-GBP, it is plausible that from the third to the 12th month post-surgery, other key drivers of weight loss, particularly the reduction in energy intake are more important in predicting WL. Further research with a larger sample size is required to increase the chances of detecting a true effect.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Manijeh Kahbazi ◽  
Marzieh Ebrahimi ◽  
Nader Zarinfar ◽  
Mohammad Arjomandzadegan ◽  
Taha Fereydouni ◽  
...  

Bacillary dysentery is a major cause of children’s admission to hospitals. To assess the probiotic and prebiotic (synbiotics) effects in children with dysentery in a randomized clinical trial, 200 children with dysentery were studied in 2 groups: the synbiotic group received 1 tablet/day of synbiotic for 3–5 days and the placebo group received placebo tablets (identical tablet form like probiotics). The standard treatment was administered for all patients. Duration of hospitalization, dysentery, fever, and the weight loss were assessed in each group. It was concluded that there was no significant difference in both groups in the baseline characteristics. The mean duration of dysentery reduced (P<0.05). The mean duration of fever has been significantly reduced in the synbiotic group (1.64±0.87days) in comparison to the placebo group (2.13±0.94days) (P<0.001). Average amount of weight loss was significantly lower in the synbiotic group in comparison to that in the placebo group (129.5±23.388grams and278±28.385grams, resp.;P<0.001). There was no significant difference in the mean duration of hospitalization in both groups (P>0.05). The use of synbiotics as an adjuvant therapy to the standard treatment of dysentery significantly reduces the duration of dysentery, fever, and rate of weight losses. The trial is registered withIRCT201109267647N1.


2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 526-526
Author(s):  
Rachel Silver ◽  
Sai Das ◽  
Michael Lowe ◽  
Susan Roberts

Abstract Objectives There is persistent controversy over the extent to which different components of energy expenditure disproportionately decrease after weight loss and contribute to weight regain through decreased energy requirements. We conducted a secondary analysis of the CALERIE I study to test the hypothesis that decreased resting metabolic rate (RMR) and energy expenditure for physical activity (EEPA) after a 6-month calorie restriction intervention would predict weight regain at 12 months, with a greater decrease in RMR than EEPA. Methods Participants (n = 46) received all food and energy-containing beverages for 6 months. Outcome measures included total energy expenditure by doubly labeled water, RMR by indirect calorimetry, and body composition by BOD POD. Predictions for RMR and EEPA were derived from baseline linear regression models including age, sex, fat mass, and fat free mass. Baseline regression coefficients were used to calculate the predicted RMR and EEPA at 6 months. Residuals were calculated as the difference between measured and predicted values and were adjusted for body weight. The presence of metabolic adaptation was evaluated by a paired t-test comparing measured and predicted RMR at 6 months. Differences between 6-month RMR and EEPA residuals were evaluated by the same method. Linear regression was used to assess the association between 6-month residuals and weight loss maintenance (% weight change, 6 to 12 months). Results Mean weight loss was 6.9% at 6 months with 2.1% regain from 6 to 12 months. No adaptation in RMR was observed at 6 months (mean residual: 19 kcal; 95% confidence interval: −9, 48; P = 0.18). However, significant adaptation was observed in EEPA (mean residual: −199 kcal; −126, −272; P &lt; 0.0001). In addition, the mean 6-month RMR residual was significantly greater than the mean 6-month EEPA residual (218 kcal; 133, 304; P &lt; 0.0001). There was no significant association between 6-month RMR or EEPA residuals and weight regain at 12 months (P = 0.56, 0.34). Conclusions There was no measurable decrease in RMR with weight loss after adjusting for changes in fat free mass and fat mass, but there was a decrease in EEPA. Changes in RMR and EEPA with weight loss over 6 months did not predict weight regain at 12 months. Funding Sources Jean Mayer USDA Human Nutrition Research Center on Aging Doctoral Scholarship; USDA agreement #8050–51000-105–01S


2018 ◽  
Vol 2 (1) ◽  
pp. 67-71
Author(s):  
Richard K.D Ephraim ◽  
Dennis Acquah ◽  
Enos Oduro Amoako ◽  
Prince Adoba ◽  
Hope Agbodzakay ◽  
...  

Background: Despite increasing prevalence of hyperglycemia leading to a type 2 diabetes mellitus (T2DM) in the urban areas, relatively little is known about its actual prevalence and associations in the rural population. This study sought to determine hyperglycemia and its associated risk factors among rural dwellers in the Effutu Municipality.Method: A simple-random cross-sectional study was conducted from January 2015 to May 2015 at the Effutu Municipality, in the Central region of Ghana. One hundred and forty-nine (149) participants were enrolled onto the study. A structured questionnaire was administered to obtain information on demography, alcohol use, tobacco use, educational status, visual challenges, sugary food intake and late-night eating. Blood samples were obtained for determination of fasting blood glucose (FBG). Body mass index (BMI), waist to hip ratio (WHR) and waist circumference (WC) were determined and hip circumference (HC) using standard protocols. Data obtained was analyzed with Statistical Package for Social Sciences (SPSS) and p < 0.05 was considered statistically significant.Results: The study showed 8.1% hyperglycemia among the rural dwellers and advanced age showed significant association with glycemic status (P = 0.0376). BMI, gender, waist hip ratio, waist circumference and hip circumference were higher in hyperglycemic participants than in normogylcaemic participants, however there was no significant difference when these parameters were compared by glycemic status.Conclusion: The prevalence of hyperglycemia in rural dwellers was 8.1% and it was significantly associated with advanced age. BMI, gender, HC, WC, WHR showed no association with hyperglycaemia.


Author(s):  
Eirik R Asheim ◽  
Jenni M Prokkola ◽  
Sergey Morozov ◽  
Tutku Aykanat ◽  
Craig R Primmer

Atlantic salmon (Salmo salar) is a species with diverse life-history strategies, to which the timing of maturation contributes considerably. Recently, the genome region including the gene vgll3 has gained attention as a locus with a large effect on salmon maturation timing, and recent studies on the vgll3 locus in salmon have indicated that its effect might be mediated through body condition and accumulation of adipose tissue. However, the cellular and physiological pathways leading from vgll3 genotype to phenotype are still unknown. Standard metabolic rate is a potentially important trait for resource acquisition and assimilation and we hypothesized that this trait, being a proxy for the maintenance energy expenditure of an individual, could be an important link in the pathway from vgll3 genotype to maturation-timing phenotype. As a first step to studying links between vgll3 and the metabolic phenotype of Atlantic salmon, we measured the standard metabolic rate of 150 first year Atlantic salmon juveniles of both sexes, originating from 14 different families with either late maturing or early maturing vgll3 genotypes. No significant difference in mass-adjusted standard metabolic rate was detected between individuals with different vgll3 genotypes, indicating that juvenile salmon of different vgll3 genotypes have similar maintenance energy requirements in the experimental conditions used and that the effects of vgll3 on body condition and maturation are not strongly related to maintenance energy expenditure in either sex at this life stage.


Author(s):  
Fatemeh Pakravanfar ◽  
Akram Ghadiri-Anari ◽  
Azadeh Nadjarzadeh ◽  
Hossein Fallahzadeh ◽  
Mahdieh Hosseinzadeh

Background: Polycystic ovarian syndrome (PCOS), one of the most common causes of endocrine disorders with irregular menstruation, is accompanied by an increase in androgen and polycystic ovarian. The aim of this study was to evaluate the effect of weight loss regimen with and without supplementation. L-carnitine affects lipid profile, insulin, and hormone resistance indices. Methods: This double-blind randomized clinical trial was conducted over women within the age range of 18 to 45 years, who referred to Yazd Diabetes Center in 2019. The participants were divided into the experimental and control groups. The intervention group received 1000 mg L-carnitine (LG = 28) and the placebo group (PG = 28) received the placebo daily. All people followed a low celery diet for 12 weeks. Anthropometric indices and body composition (weight, body mass index, waist circumference, hip circumference, fat mass, and free fat mass) were measured prior to and after the intervention. Data analysis was performed using SPSS software version 22. The independent sample t-test was used to compare the mean changes between the LG and PG. Results: At the end of the study period, patients treated with L-carnitine showed a significant decrease in waist circumference compared to the PG (change: -1 ± 3.15, P = 0.001) and no significant difference was observed between the two groups in terms of other anthropometrics indices and body composition including fat mass, body mass index, and hip circumference (P > 0.05). Conclusion: The present study showed that 1000 mg oral L-carnitine had no significant effect on body weight, body mass index, body composition, and hip circumference, but had a significant effect on waist circumference size.


2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Nikita Sanjay Israni ◽  
Thomas Cassimatis ◽  
Laura A Fletcher ◽  
Brooks P Leitner ◽  
Courtney J Duckworth ◽  
...  

Abstract Design and rationale: Obesity results from energy intake exceeding energy expenditure (EE) over a prolonged period. Many anti-obesity drugs are designed to decrease energy intake. However, their potential impact on EE is not well documented. We designed a placebo-controlled, double-blind, randomized cross-over study to determine the acute effects of several FDA-approved anti-obesity drugs on basal metabolic rate (BMR) under well-controlled conditions. Protocol and inclusion criteria: This ongoing study is limited to healthy males of all ethnicities aged 18–35 years with a BMI of 18.5 to 25.0 kg/m2. Following an overnight stay in the Metabolic Clinical Research Unit, fasting subjects were measured from 8:00am to 12:00pm in a whole-room indirect calorimeter, which was maintained at a thermoneutral temperature (26.7±0.9°C) to prevent non-shivering thermogenesis. The six treatments include placebo, caffeine as the positive control (300 mg), phentermine (37.5 mg), topiramate (200 mg), Qsymia (phentermine 15 mg / topiramate 92 mg), and naltrexone (100 mg), with a 1-week outpatient washout period after each treatment. Drug-naïve subjects received a single dose of each drug to minimize potential metabolic adaptations that may occur with weight-loss or chronic use. The prespecified primary outcome was a ≥5% increase in BMR vs. placebo for each drug. This difference can be detected for 16 subjects with 0.83 power at α=0.05 allowing for ≤25% dropout. Secondary outcomes include respiratory quotient (RQ), heart rate (HR), mean arterial pressure (MAP), and self-reported hunger. Preliminary data: To date, 7 subjects were recruited and 6 have completed the study (26.1±4.3 years, BMI 23.1±1.4 kg/m2, body fat percentage 18.4±4.1%). Interim analysis using paired t-tests shows, compared to placebo, caffeine trended towards increasing EE (1.17±0.07 vs. 1.27±0.12 kcal/min; p=0.07) and increased MAP by 5.5±4.2% (88±2 vs. 93±4; p&lt;0.05), but did not change heart rate (59±10 vs. 61±13 bpm). Naltrexone increased EE by 5.9±4.3% (p&lt;0.05). No treatments altered resting RQ compared to placebo (0.83±0.05). Phentermine increased resting HR, both alone (15.7±7.9%, p&lt;0.01) and in Qsymia (9.2±3.6%, p&lt;0.05), compared to placebo. Of the five drug-treatments, only Qsymia reduced self-reported hunger scores compared to placebo. Summary and future directions: Anti-obesity drugs may increase energy expenditure by upregulating sympathetic nervous system activity. Combined with appetite suppression, the impact on energy balance can lead to weight loss. We aim to complete our study to determine whether these drugs can acutely increase EE with minimal cardiovascular side-effects and compare our findings with long-term interventions.


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