Effectiveness of a Polyphenolic Extract (Lippia Citriodora and Hibiscus Sabdariffa) on Appetite Regulation in Overweight and Obese Grade I Population: A 8 weeks Randomized, Double-Blind, Cross-Over, Placebo-Controlled Trial

Abstract Background: Polyphenols have shown capacity to improve appetite sensation, leading to enhanced control of body weight. However, despite being related with hunger-related hormones, metabolic and mechanism is not well known.Methods: The effectiveness of a nutraceutical composed of extract to Lippia citriodora and Hibiscus sabdarrifa (Lc-Hs) for controlling satiety and hunger was analyzed in a placebo controlled (Pla) clinical intervention. The study was divided in two 60 days periods separated by 30 days length washout period. At the end of each period, volunteers (n=33; both sexes) were proposed to eat an ad-libitum meal. Meanwhile, appetite sensation was determined by visual analog scales at different times. Moreover, blood extraction was performed to evaluate hunger-related hormones (insulin, leptin, ghrelin, adiponectin, GLP-1 and peptide YY) and glycemic and lipid profile. Results: A decrease in appetite sensation was observed in Lc-Hs group, showing higher satiety quotient (Pla = 3.36 ± 2.33 %/kcal; Lc-Hs = 5.53 ± 2.91 %/kcal; p<0.0001). Area under the curve was higher in Pla compared to Lc-Hs during the test, from baseline to minute 240 (240 (Pla 9136.65 ± 2261.46 % x min-1; Lc-Hs 8279.73 ± 2745.71 % x min-1; p<0.014). Leptin values varied from baseline (Pla 12.36 ± 1.98 ng/mL; Lc-Hs 13.13 ± 1.99 ng/mL) to the end of the study (Pla 12.60 ± 2.02 ng/mL; Lc-Hs 12.06 ± 2.05 ng/mL; p<0.047). GLP-1 values varied (p<0.001) in Lc-Hs group from baseline (4.34 ± 0.49 ng/mL) to the end of the study (3.23 ± 0.52 ng/mL).Conclusion: The supplementation with the Lc-Hs extract decreases appetite sensation in overweight and obese population, reducing calorie intake after an ad-libitum meal. Due to variation on hunger-related hormones and the relationship between satiety feeling, it would be interesting to develop future research focused on the variation of the hormones themselves.

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Effectiveness of a polyphenolic extract (Lippia citriodora and Hibiscus sabdariffa) on appetite regulation in overweight and obese grade I population: an 8-week randomized, double-blind, cross-over, placebo-controlled trial

European Journal of Nutrition ◽

10.1007/s00394-021-02678-x ◽

2021 ◽

Author(s):

Ana Serna ◽

Javier Marhuenda ◽

Raúl Arcusa ◽

Silvia Pérez-Piñero ◽

Maravillas Sánchez-Macarro ◽

...

Keyword(s):

Peptide Yy ◽

Controlled Trial ◽

Area Under The Curve ◽

Day Length ◽

Calorie Intake ◽

Future Research ◽

Double Blind ◽

Lippia Citriodora ◽

Polyphenolic Extract ◽

Ad Libitum

Abstract Introduction Polyphenols have shown capacity to improve appetite sensation, leading to enhanced control of body weight. However, despite being related with hunger-related hormones, metabolic and mechanism are not well known. Methods The effectiveness of a nutraceutical composed of extract to Lippia citriodora and Hibiscus sabdarrifa (Lc-Hs) for controlling satiety and hunger was analyzed in a cross-over, placebo-controlled (Pla) clinical intervention. The study was divided in two 60-day periods separated by 30-day length wash-out period. At the end of each period, overweight and obese subjects (n = 33; age = 33.76 ± 12.23; BMI = 28.20 kg/m2 ± 2.47; fat mass 30.65 ± 8.39%; both sexes were proposed to eat an ad-libitum meal. Meanwhile, appetite sensation was determined by visual analog scales at different times. Moreover, blood extraction was performed to determine biochemical parameters (lipid and glucidic profile and safety parameters) and to evaluate hunger-related hormones (insulin, leptin, ghrelin, adiponectin, GLP-1 and peptide YY). Results A decrease in appetite sensation was observed in Lc-Hs treatment, showing higher satiety quotient (Pla = 3.36 ± 2.33%mm/kcal; Lc-Hs = 5.53 ± 2.91%mm/kcal; p < 0.0001). Area under the curve was higher in Pla compared to Lc-Hs during the test, from baseline to minute 240 (240 (Pla 9136.65 ± 2261.46% x min−1; Lc-Hs 8279.73 ± 2745.71% x min−1; p < 0.014). Energy consumption was lower for subjects treated with Lc-Hs (774.44 ± 247.77 kcal) compared to those treated with Pla (849.52 ± 246.54 kcal) (p < 0.004). Leptin values varied from baseline (Pla 12.36 ± 1.98 ng/mL; Lc-Hs 13.13 ± 1.99 ng/mL) to the end of the study (Pla 12.60 ± 2.02 ng/mL; Lc-Hs 12.06 ± 2.05 ng/mL; p < 0.047). GLP-1 values varied (p < 0.001) in Lc-Hs treatment from baseline (4.34 ± 0.49 ng/mL) to the end of the study (3.23 ± 0.52 ng/mL). Conclusion The supplementation with the Lc-Hs extract decreases appetite sensation in overweight and obese population, reducing calorie intake after an ad-libitum meal. Due to variation on hunger-related hormones and the relationship between satiety feeling, it would be interesting to develop future research focused on the variation of the hormones themselves.

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Correction: Marhuenda, J., et al. A Randomized, Double-Blind, Placebo Controlled Trial to Determine the Effectiveness a Polyphenolic Extract (Hibiscus sabdariffa and Lippia citriodora) in the Reduction of Body Fat Mass in Healthy Subjects. Foods 2020, 9(1), 55

Foods ◽

10.3390/foods9030279 ◽

2020 ◽

Vol 9 (3) ◽

pp. 279

Author(s):

Javier Marhuenda ◽

Silvia Perez-Piñero ◽

Desirée Victoria-Montesinos ◽

María Salud Abellán-Ruiz ◽

Nuria Caturla ◽

...

Keyword(s):

Body Fat ◽

Fat Mass ◽

Healthy Subjects ◽

Controlled Trial ◽

Body Fat Mass ◽

Hibiscus Sabdariffa ◽

Double Blind ◽

Double Blind Placebo ◽

Lippia Citriodora ◽

Polyphenolic Extract

The authors wish to make the following correction to this paper [...]

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A Randomized, Double-Blind, Placebo Controlled Trial to Determine the Effectiveness a Polyphenolic Extract (Hibiscus sabdariffa and Lippia citriodora) in the Reduction of Body Fat Mass in Healthy Subjects

Foods ◽

10.3390/foods9010055 ◽

2020 ◽

Vol 9 (1) ◽

pp. 55 ◽

Cited By ~ 4

Author(s):

Javier Marhuenda ◽

Silvia Perez ◽

Desirée Victoria-Montesinos ◽

María Salud Abellán ◽

Nuria Caturla ◽

...

Keyword(s):

Body Fat ◽

Fat Mass ◽

Controlled Trial ◽

The Body ◽

Hibiscus Sabdariffa ◽

Double Blind ◽

In Vivo Models ◽

Lippia Citriodora ◽

Polyphenolic Extract ◽

Treatment Of Obesity

The location and quantity of body fat determine the health risks, limiting people with obesity. Recently, polyphenols have attracted the attention of the scientific community because of their potential use for the reduction of obesity. A proprietary formula comprised of a blend of Lippia citriodora and Hibiscus sabdariffa has been recognized for its high content of polyphenols, powerful antioxidant molecules that may prevent weight gain and could be helpful for the treatment of obesity, as proven previously by in vivo models. The aim of the present study is to determine if the supplementation with Lippia citriodora and Hibiscus sabdariffa is useful for the treatment of obesity and/or weight control in subjects without a controlled diet. The intake of the extract for 84 days reduced body weight, the body mass index, and the fat mass measured with both bioimpedance and densitometry. This decrease in fat mass was observed to a greater extent, being significant, in the fat mass of the trunk (chest and torso).

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Energy intake, gastrointestinal transit, and gut hormone release in response to oral triglycerides and fatty acids in men with and without severe obesity

AJP Gastrointestinal and Liver Physiology ◽

10.1152/ajpgi.00310.2018 ◽

2019 ◽

Vol 316 (3) ◽

pp. G332-G337 ◽

Cited By ~ 4

Author(s):

Carsten Dirksen ◽

Jesper Graff ◽

Stefan Fuglsang ◽

Jens F. Rehfeld ◽

Jens J. Holst ◽

...

Keyword(s):

Fatty Acids ◽

Oleic Acid ◽

Olive Oil ◽

Energy Intake ◽

Severe Obesity ◽

Gastrointestinal Transit ◽

Calorie Intake ◽

Double Blind ◽

Gut Hormone ◽

Ad Libitum

Dietary fat, and particularly fatty acids (FAs) from hydrolyzed triglycerides (TGs), reduces appetite, whereas paradoxically, a high-fat diet leads to excess calorie intake. We therefore hypothesized that the appetite-regulating effects of FAs are perturbed in obesity. Ten men with severe obesity [median body mass index (BMI) of 51.0 kg/m2(range of 47.9–69.0)] and 10 men without obesity [BMI of 24.6 kg/m2(range of 21.7–26.8)] were recruited for a double-blind randomized crossover study. On two occasions, participants were given isocaloric (2,660 kJ) and isovolemic (80 ml) loads of either oleic acid (long-chain FA) or olive oil (TG) containing radiolabeled lipid and water markers. Postload scintigraphy, blood sampling, and assessment of appetite were performed for 10 h, after which an ad libitum meal was served. Compared with olive oil, oleic acid slowed gastric mean emptying time (GMET) for lipids ( P < 0.001), accelerated orocoecal transit time (OCTT; P = 0.005), increased postload cholecystokinin section ( P < 0.001), and suppressed ad libitum energy intake ( P = 0.028) in men with severe obesity, and similar effects were seen in the nonobese group (no group × lipid interactions). However, independent of lipid loads, GMET and OCTT were slower (GMETlipidP = 0.046; GMETwaterP = 0.003; OCTT P = 0.001), and basal and postload secretion of glucagon-like peptide-1 (GLP-1) was attenuated ( P = 0.045 and P = 0.048, respectively) in men with severe obesity compared with men without obesity. We conclude that the more potent appetite-regulating effects of oleic acid versus olive oil are unimpaired in men with severe obesity. However, regardless of lipid formulations, severe obesity is associated with slowed gastrointestinal transit and attenuated GLP-1 secretion.NEW & NOTEWORTHY Orally ingested fatty acids more efficiently reduce appetite and energy intake than triglycerides also in men with severe obesity. Men with severe obesity have delayed gastrointestinal transit and attenuated early gut hormone responses after an oral lipid load compared with men without obesity.

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Appetite regulation in overweight, sedentary men after different amounts of endurance exercise: a randomized controlled trial

Journal of Applied Physiology ◽

10.1152/japplphysiol.00680.2013 ◽

2013 ◽

Vol 115 (11) ◽

pp. 1599-1609 ◽

Cited By ~ 18

Author(s):

Mads Rosenkilde ◽

Michala Holm Reichkendler ◽

Pernille Auerbach ◽

Signe Toräng ◽

Anne Sofie Gram ◽

...

Keyword(s):

Energy Intake ◽

Endurance Exercise ◽

Acute Exercise ◽

Peptide Yy ◽

Controlled Trial ◽

High Dose ◽

Appetite Regulation ◽

Breakfast Meal ◽

Ad Libitum ◽

High Doses

Weight loss induced by endurance exercise is often disappointing, possibly due to an increase in energy intake mediated through greater appetite. The aim of this study was to evaluate fasting, postprandial, and postexercise appetite regulation after an intervention prescribing two amounts of endurance exercise. Sixty-four sedentary, overweight, healthy young men were randomized to control (CON), moderate-dose (MOD: ∼30 min/day), or high-dose (HIGH: ∼60 min/day) endurance exercise for 12 wk. Along with subjective appetite ratings, plasma ghrelin, glucagon, insulin, peptide YY3–36, glucose, free fatty acids, and glycerol were measured during fasting and in relation to a breakfast meal and an acute bout of exercise, both at baseline and at follow-up. Ad libitum lunch energy intake was evaluated 3 h after the breakfast meal. Despite different amounts of endurance exercise, the subjects lost similar amounts of fat mass (MOD: 4.2 ± 0.5 kg; HIGH: 3.7 ± 0.5 kg). Fasting and postprandial insulin decreased ∼20% in both exercise groups ( P < 0.03 vs. CON). Appetite measurements were not upregulated in the fasting and postprandial states. On the contrary, fasting and postprandial ratings of fullness and postprandial PYY3–36 increased in HIGH ( P < 0.001 vs. CON). Ad libitum lunch energy intake remained unchanged over the course of the intervention. In both exercise groups, plasma ghrelin increased in relation to acute exercise after training. Thus neither moderate nor high doses of daily endurance exercise increased fasting and postprandial measures of appetite, but a high dose of exercise was associated with an increase in fasting and meal-related ratings of fullness and satiety.

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Ultra-Processed Diets Cause Excess Calorie Intake and Weight Gain: An Inpatient Randomized Controlled Trial of Ad Libitum Food Intake

Cell Metabolism ◽

10.1016/j.cmet.2019.05.008 ◽

2019 ◽

Vol 30 (1) ◽

pp. 67-77.e3 ◽

Cited By ~ 202

Author(s):

Kevin D. Hall ◽

Alexis Ayuketah ◽

Robert Brychta ◽

Hongyi Cai ◽

Thomas Cassimatis ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Food Intake ◽

Controlled Trial ◽

Calorie Intake ◽

Randomized Controlled ◽

Ad Libitum

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Αcute effects of essential amino acid gel-based and whey protein supplements on appetite and energy intake in older women

Applied Physiology Nutrition and Metabolism ◽

10.1139/apnm-2018-0650 ◽

2019 ◽

Vol 44 (11) ◽

pp. 1141-1149 ◽

Cited By ~ 4

Author(s):

Mathew Butterworth ◽

Matthew Lees ◽

Paul Harlow ◽

Karen Hind ◽

Lauren Duckworth ◽

...

Keyword(s):

Amino Acid ◽

Whey Protein ◽

Energy Intake ◽

Essential Amino Acid ◽

Peptide Yy ◽

Energy Content ◽

Area Under The Curve ◽

Age Related ◽

Ad Libitum ◽

Acid Gel

Deficiencies in protein and energy intakes are partly responsible for age-related sarcopenia. We investigated the effects of supplements matched in essential amino acid (EAA) content (7.5 g) on energy intake and appetite. Ten women aged 69.2 ± 2.7 years completed 3 trials in a randomised, crossover design. Composite appetite scores, peptide-YY (PYY), and insulin responses to a 200-mL whey protein (WP) isolate (275 kJ), a 50-mL EAA gel (GEL, 478 kJ), or nothing as the control (CON) condition were investigated over 1 h, followed by an ad libitum breakfast. Energy intake at breakfast (CON, 1957 ± 713; WP, 1413 ± 623; GEL, 1963 ± 611 kJ) was higher in CON and GEL than in WP (both P = 0.006). After accounting for supplement energy content, energy intake in GEL was higher than in CON (P = 0.0006) and WP (P = 0.0008). Time-averaged area under the curve for composite appetite scores (CON, 74 ± 20; WP, 50 ± 22; GEL, 60 ± 16 mm) was higher in CON than WP (P = 0.015). Time-averaged area under the curve for PYY (CON, 87 ± 13; WP, 119 ± 27; GEL, 97 ± 22 pg·mL−1) was higher in WP than CON (P = 0.009) and GEL (P = 0.012). In conclusion, supplementation with WP facilitated an increase in protein intake, whereas supplementation with GEL increases in both energy and protein intakes, when consumed before an ad libitum breakfast. Such findings highlight potential gel-based EAA supplementation intake for addressing age-related sarcopenia.

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Influence of Cinnamon on Glycemic Control in Individuals With Prediabetes: A Randomized Controlled Trial

Journal of the Endocrine Society ◽

10.1210/jendso/bvaa094 ◽

2020 ◽

Vol 4 (11) ◽

Cited By ~ 1

Author(s):

Giulio R Romeo ◽

Junhee Lee ◽

Christopher M Mulla ◽

Youngmin Noh ◽

Casey Holden ◽

...

Keyword(s):

Glucose Tolerance ◽

Controlled Trial ◽

Area Under The Curve ◽

Cost Effective ◽

Tolerance Test ◽

Controlled Clinical Trial ◽

Oral Glucose ◽

Serious Adverse Events ◽

Double Blind ◽

Favorable Safety

Abstract Context The identification of adjunct safe, durable, and cost-effective approaches to reduce the progression from prediabetes to type 2 diabetes (T2D) is a clinically relevant, unmet goal. It is unknown whether cinnamon’s glucose-lowering properties can be leveraged in individuals with prediabetes. Objective The objective of this work is to investigate the effects of cinnamon on measures of glucose homeostasis in prediabetes. Design, Setting, Participants, and Intervention This double-blind, placebo-controlled, clinical trial randomly assigned adult individuals meeting any criteria for prediabetes to receive cinnamon 500 mg or placebo thrice daily (n = 27/group). Participants were enrolled and followed at 2 academic centers for 12 weeks. Main Outcome Measures Primary outcome was the between-group difference in fasting plasma glucose (FPG) at 12 weeks from baseline. Secondary end points included the change in 2-hour PG of the oral glucose tolerance test (OGTT), and the change in the PG area under the curve (AUC) derived from the OGTT. Results From a similar baseline, FPG rose after 12 weeks with placebo but remained stable with cinnamon, leading to a mean between-group difference of 5 mg/dL (P < .05). When compared to the respective baseline, cinnamon, but not placebo, resulted in a significant decrease of the AUC PG (P < .001) and of the 2-hour PG of the OGTT (P < .05). There were no serious adverse events in either study group. Conclusions In individuals with prediabetes, 12 weeks of cinnamon supplementation improved FPG and glucose tolerance, with a favorable safety profile. Longer and larger studies should address cinnamon’s effects on the rate of progression from prediabetes to T2D.

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Modafinil for fatigue associated with docetaxel-based chemotherapy: A randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.5_suppl.211 ◽

2012 ◽

Vol 30 (5_suppl) ◽

pp. 211-211

Author(s):

Elizabeth J. Hovey ◽

Paul L. De Souza ◽

Gavin M. Marx ◽

Phillip Parente ◽

Tal Rapke ◽

...

Keyword(s):

Primary Endpoint ◽

Controlled Trial ◽

Area Under The Curve ◽

Study Medication ◽

Double Blind ◽

Patients With Cancer ◽

Parallel Group ◽

Grade 3 ◽

Chemotherapy Patients ◽

Md Anderson

211 Background: Chemotherapy-induced fatigue is a common complaint for patients with cancer. We investigated whether modafinil, a psychostimulant, could reduce fatigue in patients on chemotherapy. Methods: A multicenter, randomized, double-blind, placebo-controlled, parallel group study was conducted in patients with metastatic prostate or breast cancer suffering significant chemotherapy-related fatigue whilst undergoing docetaxel-based chemotherapy. Patients were enrolled at the start of their 3rdor subsequent cycles of docetaxel which was continued for up to four further cycles (defined here as ‘treatment periods’). Patients were randomized 2:1 to receive modafinil 200mg daily or placebo for 15 days during each treatment period. Fatigue was evaluated by the MD Anderson Symptom Inventory (MDASI). The primary endpoint was MDASI area under the curve (AUC) during the first 7 days of study medication for the first two treatment periods (possible range 0-70). Other validated tools were used to record disturbances in sleep, mood and functional status. Results: Eighty-three patients (65 with prostate cancer) were randomized and received at least one dose of study medication. The number of grade 3 or 4 adverse events (AEs) was 16/55 (29.1%) in the modafinil group and 5/28 (17.9%) in the placebo group. The toxicity profile was largely consistent with docetaxel-based chemotherapy and with previously reported AEs associated with modafinil use in the community; 11 AEs were possibly related to docetaxel; 1 to modafinil and 9 to neither treatment. Conclusions: Managing chemotherapy-related fatigue remains a major challenge. Despite not reaching the primary endpoint, there was a consistent trend towards improvement of chemotherapy-related fatigue in the modafinil arm. Further studies are needed to better understand the clinical implications of these findings. Funding sanofi-aventis; Study ID NCT00917748 . [Table: see text]

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Abstract 12868: Morphine Decreases Ticagrelor Concentrations but Not Its Effects: A Randomized, Double-Blind, Placebo-Controlled Trial

Circulation ◽

10.1161/circ.132.suppl_3.12868 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Eva-Luise Hobl ◽

Birgit Reiter ◽

Thomas Stimpfl ◽

Christian Schoergenhofer ◽

Michael Schwameis ◽

...

Keyword(s):

Drug Interactions ◽

Active Metabolite ◽

Drug Exposure ◽

Controlled Trial ◽

Plasma Concentrations ◽

Area Under The Curve ◽

Blood Platelet ◽

Loading Dose ◽

Double Blind ◽

Double Blind Placebo

Introduction: Our recent drug interaction trial with clopidogrel showed that morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in susceptible individuals. This study examined possible drug-drug interactions between ticagrelor and morphine. Hypothesis: We hypothesized that the pharmacodynamic consequences of drug-drug interactions would be less between morphine and ticagrelor. Methods: Twenty-four healthy subjects received a loading dose of 180mg ticagrelor together with placebo or 5mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and ticagrelor effects were measured by platelet function tests. Results: Concomitant i.v. injection of morphine slows drug resorption of ticagrelor and its active metabolite (p<0.05) by one hour and decreases plasma levels of ticagrelor and its active metabolite (by 25-31%; p < 0.03) and the drug exposure (area under the curve by 22-23%; p < 0.01). Importantly, however, the effects of ticagrelor on platelet aggregation in whole blood, platelet plug formation, and vasodilator-stimulated phosphoprotein (VASP) phosphorylation are not affected by morphine. Conclusions: Morphine co-administration moderately decreases ticagrelor plasma concentrations but does not inhibit ist effects. Therefore, a 180 mg loading dose of ticagrelor appears to provide consistent and reliable platelet inhibition when morphine has to be given for pain relief.

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