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Diabetes, Obesity & Metabolism Feb 2021To evaluate the effect of oral semaglutide on energy intake and appetite in subjects with type 2 diabetes (T2D). (Randomized Controlled Trial)
Randomized Controlled Trial
AIM
To evaluate the effect of oral semaglutide on energy intake and appetite in subjects with type 2 diabetes (T2D).
MATERIALS AND METHODS
In this randomized, double-blind, placebo-controlled, two-period cross-over trial, 15 subjects with T2D received 12 weeks of treatment with once-daily oral semaglutide (4-week dose escalation from 3 to 7 to 14 mg) followed by placebo, or vice versa. Energy intake was measured during an ad libitum lunch, evening meal and snack box after a standard breakfast. Appetite ratings were measured using a visual analogue scale after standard and fat-rich breakfasts. Other assessments included eating and craving control (using the Control of Eating Questionnaire), and changes in body weight and composition.
RESULTS
Following a standard breakfast, total daily ad libitum energy intake was significantly lower (38.9%) with oral semaglutide versus placebo in 13 evaluable subjects (estimated treatment difference, -5096.0 kJ; 95% CI -7000.0, -3192.1; P = .0001). After a fat-rich breakfast, there were significant differences in favour of oral semaglutide versus placebo for measures of satiety, hunger and for overall appetite score, with no significant differences following a standard breakfast. Fewer food cravings and better eating control were seen with oral semaglutide versus placebo. Overall, mean body weight decreased by 2.7 kg with oral semaglutide and 0.1 kg with placebo, mostly attributable to body fat mass loss.
CONCLUSION
After 12 weeks of treatment, ad libitum energy intake was lower with oral semaglutide versus placebo, resulting in reduced body fat mass, and was associated with increased satiety and fullness after a fat-rich breakfast, and improved eating control.
TRIAL REGISTRATION NUMBER
NCT02773381.
Topics: Appetite; Body Weight; Breakfast; Cross-Over Studies; Diabetes Mellitus, Type 2; Eating; Energy Intake; Food Preferences; Glucagon-Like Peptides; Humans
PubMed: 33184979
DOI: 10.1111/dom.14255 -
Nutrients May 2021Postprandial hyperglycemia (PPHG) is strongly linked with the future development of cardiovascular complications in type 2 diabetes (T2D). Hence, reducing postprandial... (Review)
Review
Postprandial hyperglycemia (PPHG) is strongly linked with the future development of cardiovascular complications in type 2 diabetes (T2D). Hence, reducing postprandial glycemic excursions is essential in T2D treatment to slow progressive deficiency of β-cell function and prevent cardiovascular complications. Most of the metabolic processes involved in PPHG, i.e., β-cell secretory function, GLP-1 secretion, insulin sensitivity, muscular glucose uptake, and hepatic glucose production, are controlled by the circadian clock and display daily oscillation. Consequently, postprandial glycemia displays diurnal variation with a higher glycemic response after meals with the same carbohydrate content, consumed at dusk compared to the morning. T2D and meal timing schedule not synchronized with the circadian clock (i.e., skipping breakfast) are associated with disrupted clock gene expression and is linked to PPHG. In contrast, greater intake in the morning (i.e., high energy breakfast) than in the evening has a resetting effect on clock gene oscillations and beneficial effects on weight loss, appetite, and reduction of PPHG, independently of total energy intake. Therefore, resetting clock gene expression through a diet intervention consisting of meal timing aligned to the circadian clock, i.e., shifting most calories and carbohydrates to the early hours of the day, is a promising therapeutic approach to improve PPHG in T2D. This review will focus on recent studies, showing how a high-energy breakfast diet (Bdiet) has resetting and synchronizing actions on circadian clock genes expression, improving glucose metabolism, postprandial glycemic excursions along with weight loss in T2D.
Topics: Appetite; Blood Glucose; Breakfast; Circadian Clocks; Circadian Rhythm Signaling Peptides and Proteins; Diabetes Mellitus, Type 2; Diet, Diabetic; Energy Intake; Feeding Behavior; Humans; Hyperglycemia; Meals; Postprandial Period; Time Factors; Weight Loss
PubMed: 34063109
DOI: 10.3390/nu13051558 -
Diabetes Care Sep 2022Inhibiting sodium-glucose cotransporters (SGLTs) improves glycemic and cardiovascular outcomes in patients with type 2 diabetes (T2D). We investigated the differential... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Inhibiting sodium-glucose cotransporters (SGLTs) improves glycemic and cardiovascular outcomes in patients with type 2 diabetes (T2D). We investigated the differential impact of selective SGLT2 inhibition and dual inhibition of SGLT1 and SGLT2 on multiple parameters.
RESEARCH DESIGN AND METHODS
Using a double-blind, parallel-group design, we randomized 40 patients with T2D and hypertension to receive the dual SGLT1 and SGLT2 inhibitor sotagliflozin 400 mg or the selective SGLT2 inhibitor empagliflozin 25 mg, with preexisting antihypertensive treatment, for 8 weeks. In an in-house testing site, mixed-meal tolerance tests (MMTTs) and other laboratory and clinical evaluations were used to study metabolic, intestinal, cardiovascular, and urinary parameters over 24 h.
RESULTS
Changes from baseline in glycemic and blood pressure control; intestinal, urine, and metabolic parameters; and cardiovascular biomarkers were generally similar with sotagliflozin and empagliflozin. During the breakfast MMTT, sotagliflozin significantly reduced incremental area under the curve (AUC) values for postprandial glucose, insulin, and glucose-dependent insulinotropic polypeptide (GIP) and significantly increased incremental AUCs for postprandial glucagon-like peptide 1 (GLP-1) relative to empagliflozin, consistent with sotagliflozin-mediated inhibition of intestinal SGLT1. These changes waned during lunch and dinner MMTTs. Both treatments significantly lowered GIP incremental AUCs relative to baseline over the 14 h MMTT interval; the most vigorous effect was seen with sotagliflozin soon after start of the first meal of the day. No serious or severe adverse events were observed.
CONCLUSIONS
Changes from baseline in glycemic and blood pressure control, cardiovascular biomarkers, and other parameters were comparable between sotagliflozin and empagliflozin. However, sotagliflozin but not empagliflozin inhibited intestinal SGLT1 after breakfast as shown by larger changes in postprandial glucose, insulin, GIP, and GLP-1 AUCs, particularly after breakfast. Additional study is warranted to assess the clinical relevance of transient SGLT1 inhibition and differences in incretin responses (NCT03462069).
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Gastric Inhibitory Polypeptide; Glucagon-Like Peptide 1; Glycosides; Humans; Hypoglycemic Agents; Insulin; Sodium-Glucose Transporter 2; Sodium-Glucose Transporter 2 Inhibitors
PubMed: 35817022
DOI: 10.2337/dc21-2166 -
The Journal of Nutrition Jul 2020Although daily protein intake (PI) has been reported to be essential for regulating muscle mass, the distribution of daily PI in individuals is typically the lowest at... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Although daily protein intake (PI) has been reported to be essential for regulating muscle mass, the distribution of daily PI in individuals is typically the lowest at breakfast and skewed toward dinner. Skewed protein intake patterns and inadequate PI at breakfast were reported to be negative factors for muscle maintenance.
OBJECTIVES
This study examined whether a protein-enriched meal at breakfast is more effective for muscle accretion compared with the typical skewed PI pattern.
METHODS
This 12-wk, parallel-group, randomized clinical trial included 26 men (means ± SEs; age: 20.8 ± 0.4 y; BMI: 21.8 ± 0.4 kg/m2). The "high breakfast" (HBR) group (n = 12) consumed a protein-enriched meal at breakfast providing a PI of 0.33 g/kg body weight (BW); their PI at lunch (0.46 g/kg BW) and dinner (0.48 g/kg BW) provided an adequate overall daily PI (1.30 g/kg BW/d). The "low breakfast" (LBR) group (n = 14) consumed 0.12 g protein/kg BW at breakfast; intakes at lunch (0.45 g/kg BW) and dinner (0.83 g/kg BW) yielded the same daily PI as in the HBR group. The participants performed supervised resistance training (RT) 3 times per week (75-80% 1-repetition maximum; 3 sets × 10 repetitions). DXA was used to measure the primary outcome variable, that is, total lean soft tissue mass (LTM).
RESULTS
The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups. After the intervention, increases in total LTM were significant in both groups, with that in the HBR group (2.5 ± 0.3 kg) tending to be greater than that in the LBR group (1.8 ± 0.3 kg) (P = 0.06), with a large effect size (Cohen d = 0.795).
CONCLUSIONS
For RT-induced muscle hypertrophy in healthy young men, consuming a protein-enriched meal at breakfast and less protein at dinner while achieving an adequate overall PI is more effective than consuming more protein at dinner.This study was registered at University hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000037583 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042763).
Topics: Adolescent; Adult; Dietary Proteins; Humans; Male; Meals; Muscle, Skeletal; Resistance Training; Young Adult
PubMed: 32321161
DOI: 10.1093/jn/nxaa101 -
Nutrients Dec 2022This study aimed to examine the effect of high protein breakfast diet with or without lunch on the postprandial glucose level during the day. A randomized, crossover... (Randomized Controlled Trial)
Randomized Controlled Trial
This study aimed to examine the effect of high protein breakfast diet with or without lunch on the postprandial glucose level during the day. A randomized, crossover design that recruited 12 healthy young participants (three men and nine women) was performed and four trials (normal breakfast + skipped lunch, high protein breakfast + skipped lunch, normal breakfast + lunch, and high protein breakfast + lunch) were conducted in two weeks. During each trial, breakfast, lunch, and dinner on the trial day, and dinner before the trial day, were provided as test meals, and the meal timing was fixed. Continuous glucose monitoring (CGM) was used to assess the blood glucose level during the whole experiment. Incremental area under the curve (iAUC) of the postprandial glucose level was calculated. The results suggested that compared with normal breakfast, high protein breakfast suppressed the 3 h iAUC of postprandial glucose level after breakfast (p < 0.05 or p < 0.0001) and 1.5 h iAUC after lunch (p < 0.01). During lunch, high protein breakfast diet suppressed the dinner and overall day postprandial glucose level (p < 0.05 vs. normal breakfast), but no significant difference was observed when skipping lunch. Our findings indicate that high protein breakfast could suppress the breakfast postprandial glucose level, as well as following lunch and dinner, but this effect on dinner was attenuated when skipping lunch.
Topics: Adult; Female; Humans; Male; Blood Glucose; Blood Glucose Self-Monitoring; Breakfast; Cross-Over Studies; Diabetes Mellitus, Type 2; Diet, High-Protein; Hyperglycemia; Lunch; Meals; Postprandial Period; Double-Blind Method
PubMed: 36615743
DOI: 10.3390/nu15010085 -
Diabetes, Obesity & Metabolism Jul 2021To assess the effects of oral semaglutide on postprandial glucose and lipid metabolism, and gastric emptying, in subjects with type 2 diabetes (T2D). (Randomized Controlled Trial)
Randomized Controlled Trial
AIM
To assess the effects of oral semaglutide on postprandial glucose and lipid metabolism, and gastric emptying, in subjects with type 2 diabetes (T2D).
MATERIALS AND METHODS
In this randomized, double-blind, single-centre, crossover trial, subjects with T2D received once-daily oral semaglutide (escalated to 14 mg) followed by placebo, or vice versa, over two consecutive 12-week periods. Glucose and lipid metabolism, and gastric emptying (paracetamol absorption) were assessed before and after two types of standardized meals (standard and/or fat-rich) at the end of each treatment period. The primary endpoint was area under the glucose 0-5-h curve (AUC ) after the standard breakfast.
RESULTS
Fifteen subjects were enrolled (mean age 58.2 years, HbA1c 6.9%, body weight 93.9 kg, diabetes duration 3.1 years; 13 [86.7%] males). Fasting concentrations of glucose were significantly lower, and C-peptide significantly greater, with oral semaglutide versus placebo. Postprandial glucose (AUC ) was significantly lower with oral semaglutide versus placebo (estimated treatment ratio, 0.71; 95% CI, 0.63, 0.81; p < .0001); glucose incremental AUC (iAUC ) and glucagon AUC were also significantly reduced, with similar results after the fat-rich breakfast. Fasting concentrations of triglycerides, very low-density lipoprotein (VLDL) and apolipoprotein B48 (ApoB48) were significantly lower with oral semaglutide versus placebo. AUC for triglycerides, VLDL and ApoB48, and triglycerides iAUC , were significantly reduced after oral semaglutide versus placebo. During the first postprandial hour, gastric emptying was delayed (a 31% decrease in paracetamol AUC ) with oral semaglutide versus placebo. One serious adverse event (acute myocardial infarction) occurred during oral semaglutide treatment.
CONCLUSION
Oral semaglutide significantly improved fasting and postprandial glucose and lipid metabolism, and delayed gastric emptying.
Topics: Blood Glucose; Diabetes Mellitus, Type 2; Double-Blind Method; Gastric Emptying; Glucagon-Like Peptides; Glucose; Humans; Hypoglycemic Agents; Lipid Metabolism; Male; Middle Aged; Postprandial Period
PubMed: 33710717
DOI: 10.1111/dom.14373 -
The American Journal of Clinical... Jul 2023In type 2 diabetes (T2D), consuming carbohydrates results in a rapid and large increase in blood glucose, particularly in the morning when glucose intolerance is highest. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
In type 2 diabetes (T2D), consuming carbohydrates results in a rapid and large increase in blood glucose, particularly in the morning when glucose intolerance is highest.
OBJECTIVES
We investigated if a low-carbohydrate (LC) breakfast (∼465 kcal: 25 g protein, 8 g carbohydrates, and 37 g fat) could improve glucose control in people with T2D when compared with a low-fat control (CTL) breakfast (∼450 kcal:20 g protein, 56 g carbohydrates, and 15 g fat).
METHODS
Participants with T2D (N = 121, 53% women, mean age 64 y) completed a remote 3-month parallel-group randomized controlled trial comparing a LC with standard low-fat guideline CTL breakfast. The change in HbA1c was the prespecified primary outcome. Continuous glucose monitoring, self-reported anthropometrics, and dietary information were collected for an intention-to-treat analysis.
RESULTS
HbA1c was reduced (-0.3%; 95% CI: -0.4%, -0.1%) after 12 wks of a LC breakfast, but the between-group difference in HbA1c was of borderline statistical significance (-0.2; 95% CI: -0.4, 0.0; P = 0.06). Self-reported total daily energy (-242 kcal; 95% CI: -460, -24 kcal; P = 0.03) and carbohydrate (-73 g; 95% CI: -101, -44 g; P < 0.01) intake were lower in the LC group but the significance of this difference is unclear. Mean and maximum glucose, area under the curve, glycemic variability, standard deviation, and time above range were all significantly lower, and time in the range was significantly higher, in the LC group compared with CTL (all P < 0.05).
CONCLUSIONS
Advice and guidance to consume a LC breakfast appears to be a simple dietary strategy to reduce overall energy and carbohydrate intake and improve several continuous glucose monitoring variables when compared with a CTL breakfast in persons living with T2D. The trial was registered at clinicaltrials.gov as NCT04550468.
Topics: Humans; Female; Middle Aged; Male; Blood Glucose; Breakfast; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Dietary Carbohydrates; Blood Glucose Self-Monitoring; Glycemic Control; Diet, Fat-Restricted; Glucose
PubMed: 37257563
DOI: 10.1016/j.ajcnut.2023.04.032 -
International Journal of Epidemiology Oct 2023Food intake plays a pivotal role in regulating circadian rhythms, which modulate glucose and lipid homeostasis. However, studies investigating the association of meal...
BACKGROUND
Food intake plays a pivotal role in regulating circadian rhythms, which modulate glucose and lipid homeostasis. However, studies investigating the association of meal timing and type 2 diabetes (T2D) incidence are lacking. The objective of this study was to investigate the longitudinal associations of meal timing, number of eating occasions and night-time fasting duration with incidence of T2D.
METHODS
In total, 103 312 adults [79% women, mean age at baseline = 42.7 (SD = 14.6)] from the NutriNet-Santé cohort (2009-21) were included. Participants' meal timings and frequency were assessed using repeated 24-h dietary records and averaged from the first 2 years of follow-up (5.7 records/participant). Associations of meal timing, number of eating occasions and night-time fasting duration with incidence of T2D were assessed by using multivariable Cox proportional hazard models adjusted for known risk factors.
RESULTS
During a median follow-up of 7.3 years, 963 new cases of T2D were ascertained. Compared with participants habitually having a first meal before 8AM, those eating after 9AM had a higher incidence of T2D (HR = 1.59, 95% CI 1.30-1.94). Time of last meal was not associated with T2D incidence. Each additional eating episode was associated with a lower incidence of T2D (HR = 0.95, 95% CI 0.90-0.99). Night-time fasting duration was not associated with T2D incidence, except in participants having breakfast before 8AM and fasting for >13 h overnight (HR = 0.47, 95% CI 0.27-0.82).
CONCLUSIONS
In this large prospective study, a later first meal was associated with a higher incidence of T2D. If confirmed in other large-scale studies, an early breakfast should be considered in preventing T2D.
Topics: Adult; Humans; Female; Male; Diabetes Mellitus, Type 2; Feeding Behavior; Prospective Studies; Incidence; Risk Factors; Fasting
PubMed: 37328450
DOI: 10.1093/ije/dyad081 -
Journal of the American Board of Family... 2021Recent studies suggest that intermittent fasting or skipping breakfast may be good strategies for weight loss and better health. The objective of this study was to...
BACKGROUND
Recent studies suggest that intermittent fasting or skipping breakfast may be good strategies for weight loss and better health. The objective of this study was to determine whether regular breakfast is associated with overall or cardiovascular mortality.
METHODS
Cohort study with follow-up mortality data from the NHANES 1999-2002. National weighted sample. Outcomes were overall and cardiovascular mortality; secondary was fiber intake.
RESULTS
Out of 5761 participants, there were 4778 (82.9%) identified as breakfast eaters and 2027 deaths (35.2%); 469 (23.1%) deaths were due to cardiovascular diseases. The average daily intake of calories was 2015, and fiber was 16.3 g/day. A total of 17.7%, 66.0%, and 11.4% of participants had diabetes, hypertension, and cardiovascular diseases, respectively. Analysis showed breakfast eaters were older, had lower body mass index, and ate more calories and fiber daily than non-breakfast eaters. Cox proportional hazard regression analyses showed that compared to non-breakfast eaters, the breakfast eaters were less likely to experience mortality after multivariable adjustments (overall mortality: hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.57-0.84 and cardiovascular mortality: HR, 0.45; 95% CI, 0.32-0.63). For the breakfast eaters, fiber intake >25 g/day was associated with 21% (HR, 0.79; 95% CI, 0.66-0.96) reduction in all-cause mortality after multivariable adjustments.
CONCLUSIONS
Regular daily intake of breakfast appears to be associated with lower overall and cardiovascular mortality, particularly when consuming fiber >25 g/day. Further studies examining specific breakfast foods and the timing of foods would be helpful.
Topics: Breakfast; Cohort Studies; Humans; Nutrition Surveys
PubMed: 34312261
DOI: 10.3122/jabfm.2021.04.210044 -
Journal of Affective Disorders Mar 2024Depression is a significant, pervasive, global public health problem, associated with many factors, such as diet, social factors, and lifestyle habits. We aimed to...
BACKGROUND
Depression is a significant, pervasive, global public health problem, associated with many factors, such as diet, social factors, and lifestyle habits. We aimed to evaluate the association between eating breakfast, dietary inflammatory index (DII) and depression, and to verify the mediating role of DII on the effect of eating breakfast on depression.
METHODS
21,865 participants from the National Health and Nutrition Examination Survey (NHANES) from 2007 to 2018 were included in this study. Binary logistic regression and mediated effect analysis were conducted to analyze the associations between eating breakfast, DII and depression. Dietary inflammation was divided into pro-inflammatory diet and anti-inflammatory diet according to the DII.
RESULTS
Both pro-inflammatory diet and skipping breakfast were risk factors for depression. After adjusting for covariables, compared with participants reporting breakfast in both recalls, reporting breakfast in one recall had a higher OR 95%CI (1.54(1.20, 1.98)) of depression. These associations in stratified analysis and sensitivity analysis without cardiovascular diseases (CVD) and diabetes were robust. DII mediated the association between eating breakfast and depression, the proportion of participants who reported breakfast in one recall and no recall was 26.15 % and 26.67 %, respectively.
LIMITATIONS
This was a cross-sectional study that couldn't argue for the cause-effect relationship. Moreover, the confounding factor regarding medication use was not accounted for due to limited data.
CONCLUSIONS
Skipping breakfast may increase the risk of depression by raising DII. And our study supported the essential role of regular breakfast and the anti-inflammatory diet in reducing the risk of depression.
Topics: Humans; Nutrition Surveys; Depression; Cross-Sectional Studies; Breakfast; Diet; Inflammation; Anti-Inflammatory Agents
PubMed: 38070746
DOI: 10.1016/j.jad.2023.12.015