Effect of time restricted eating on body weight and fasting glucose in participants with obesity: results of a randomized, controlled, virtual clinical trial.2021
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Влияние ограниченного по времени приема пищи на массу тела и уровень глюкозы натощак у участников с ожирением: результаты рандомизированного контролируемого виртуального клинического исследования. 2021
Сгенерированная сводка:
Еда с ограничением по времени (TRE) - это новое диетическое вмешательство для снижения веса, которое, как предполагается, усиливает метаболические преимущества ночного голодания / кетоза. В этом пилотном исследовании изучалась эффективность ежедневного 14-часового метаболического голодания (14:10 TRE, начало после обеда, «перекус натощак» через 12 часов и завершение завтрака через 14 часов) в сочетании с коммерческой программой управления массой тела с учетом массы тела. и уровень глюкозы в крови натощак (FBG) у лиц с ожирением. Мы также исследовали влияние низкокалорийных, жирных, низкоуглеводных и низкобелковых «перекусов натощак» на уровень глюкозы в крови.
Это 8-недельное рандомизированное контролируемое клиническое испытание включало мужчин и женщин (ИМТ ≥ 30 кг / м) в период с июня по октябрь 2020 г. Процедуры исследования проводились дистанционно. Участники были рандомизированы на 14:10 или 12-часовой TRE (12:12, активный компаратор) и прописали диету (с контролем по калорийности и составу макроэлементов) и программу упражнений, которая включала еженедельное индивидуальное консультирование и поддержку. Первичным результатом было изменение массы тела по сравнению с исходным уровнем в группе 14:10.
Из 78 рандомизированных участников 60 (n = 30 / группа) завершили 8 недель. Среднее значение LS по сравнению с исходным уровнем веса в группе 14:10 составило -8,5% (95% ДИ от -9,6 до -7,4; P <0,001) и -7,1% (от -8,3 до -5,8; P <0,001) в 12 группах. : 12 группа (разница между группами -1,4%; -2,7 до -0,2; P <0,05). Статистически значимое изменение среднего LS от исходного уровня до 8 недели в FBG в группе 14:10 составило -7,6 мг / дл (95% ДИ от -15,1 до -0,1; P <0,05), но не в группе 12:12 ( -3,1 мг / дл, от -10,0 до 3,7; P = NS). Оба вмешательства привели к большему снижению ВБГ у участников с повышенным уровнем ВБГ (≥100 мг / дл) на исходном уровне (оба P <0,05).
У участников с ожирением, которые завершили 8 недель графика TRE 14:10 в сочетании с коммерческой программой похудания, наблюдалась статистически значимая и клинически значимая потеря веса и улучшения в FBG.
Abstract:
Conclusion
In participants with obesity who completed 8 weeks of the 14:10 TRE schedule combined with a commercial weight loss program, there was statistically significant and clinically meaningful weight loss and improvements in FBG.
Result
Of the 78 randomized participants, 60 (, = 30/group) completed 8 weeks. The LS mean change from baseline in weight in the 14:10 group was −8.5% (95% CI −9.6 to −7.4; , < 0.001) and −7.1% (−8.3 to −5.8; , < 0.001) in the 12:12 group (between group difference −1.4%; −2.7 to −0.2; , < 0.05). There was a statistically significant LS mean change from baseline to week 8 in FBG in the 14:10 group of −7.6 mg/dl (95% CI −15.1 to −0.1; , < 0.05) but not in the 12:12 group (−3.1 mg/dl, −10.0 to 3.7; , = NS). Both interventions resulted in a larger reduction in FBG in participants with elevated FBG (≥100 mg/dl) at baseline (both , < 0.05).,The study took place from June 2020 to October 2020. Seventy-eight participants were randomized and included in the intent to treat population; all provided at least one baseline body weight or FBG measurement (Fig. ,). Sixty participants completed the study (, = 30/group) and were included in the analysis of study completers. Reasons for dropouts are summarized in Fig. ,. The medical reasons for leaving the study included a new diagnosis of Parkinson’s disease (12:12 group) and a newly diagnosed food allergy (14:10 group). Six participants dropped out due to a scheduling conflict, i.e., they had to return to work due to changes in COVID restrictions and were no longer able to comply with study procedures.,Participant flow.,Demographics and baseline characteristics were generally similar across groups. Most participants were women (88%). Participants who completed the study had a mean ± SD age of 44 ± 11 years and baseline BMI of 38.9 ± 7.7 kg/m,. Baseline body weight was slightly higher in the 14:10 group than the 12:12 group but the difference between groups was not statistically significant (, < 0.05; Table ,). Baseline data was generally similar between the completer and ITT populations (Tables , and ,). Throughout the study, follow-up was provided on a weekly basis and as needed to address patient questions or concerns. There were no substantive differences between groups in the frequency or nature of interactions with the study doctor or coaches between the 14:10 or 12:12 groups.,Change from baseline in body weight and fasting blood glucose in study completers.,Data are LS mean ± SD., fasting blood glucose.,ANOVA of the change from baseline to Week 8.,ANOVA of the change from baseline using repeated measures method that included all postbaseline measurements.,Change from baseline in body weight and fasting blood glucose in the intent to treat population.,Data are LS mean ± SD. The intent to treat population includes all randomized participants. Missing data were imputed using the last observation carried forward method., fasting blood glucose.,Among participants who completed the study, body weight decreased from baseline to Week 8 in both the 14:10 and 12:12 groups (Fig. ,). Over the course of 8 weeks, the LS mean change from baseline was −10.7 kg (−8.5%) in the 14:10 group (Table ,, , < 0.001) and −8.9 kg (7.1%) in the 12:12 group (Table ,, , < 0.001). The change in body weight was also significantly different between groups with a between group LS mean difference of 1.9 kg or 1.4% (Table ,, , < 0.05). The repeated measures analysis of the change from baseline in body weight yielded similar results (Table ,). The average weight loss was greater than 0 at every timepoint and the overall averages were highly significant for each group. Moreover, the group difference was statistically significant from 0. In the ITT population, the change in body weight from baseline to Week 8 was statistically significant in both the 14:10 and 12:12 groups, but the between groups difference was not statistically significant (Table ,)., Change in body weight. , Change in percent body weight. Data are mean ± SE for the completer population (, = 30). *, < 0.05 for comparison of the adjusted LS mean change from baseline to Week 8 in the 14:10 group compared to the 12:12 group.,Changes in FBG in study completers over the course of the study are shown in Fig. ,. In the 14:10 group, the LS mean change from baseline in FBG was −7.6 mg/dl from baseline to Week 8 (Table ,, , < 0.05). In the 12:12 group, the LS mean change from baseline in FBG was −3.1 mg/dl (not statistically significant, Table ,). The difference in the change from baseline in FBG between the 14:10 and 12:12 groups was not statistically significant (Table ,). The repeated measure analysis showed that the decreases in FBG were significant at all timepoints and for overall post-baseline averages in each group (Table ,). Similarly, the difference between groups was not significantly different from 0. In the ITT population, the change in FBG from baseline to Week 8 was statistically significant in both the 14:10 and 12:12 groups, but the between groups difference was not statistically significant (Table ,)., Change in FBG for all participants. Data are mean ± SE for the completer population (, = 30). , Change in FBG for participants with baseline levels ≥100 mg/dl. Data are mean ± SE for participants in the completer population with a baseline FBG of ≥100 mg/dl (, = 12/group). FBG fasting blood glucose.,We analyzed the change from baseline to Week 8 in FBG in subset of participants who had elevated FBG levels (≥100 mg/dl) at the beginning of the study (Fig. ,, , = 12/group). There were statistically significant reductions from baseline in FBG in both groups. The LS mean change in FBG was −17.6 mg/dl for the 14:10 group and −11.2 mg/dl for the 12:12 group (Table ,, both , < 0.05).,In the 12:12 group, mean blood glucose levels were similar at hour 12 (immediately prior to breakfast), increased slightly at hour 14 (2 h after breakfast), and decreased back to near fasting levels by hour 15 (Fig. ,). Week 8 blood glucose measurements were obtained on separate days either with or without the fasting snack (Fig. ,). Consumption of the fasting snack at hour 12 had no effect on blood glucose levels at hour 14. In the 14:10 group, breakfast was consumed after the 14-hour FBG measurement, which resulted in a significant elevation in blood glucose levels at hour 15 (approximately 1 h after the start of breakfast)., Change in blood glucose after a breakfast meal for 12:12 study completers (, = 30). Participants ate breakfast after the 12-hour FBG measurement. , Blood glucose response to a fasting snack and breakfast meal for 14:10 study completers at baseline (no fasting snack) and Week 8 (no fasting snack) (, = 30). Participants ate the fasting snack after the 12-h blood glucose measurement and ate breakfast after the 14-h blood glucose measurement. Data are mean ± SE.,All participants in the 14:10 group reported that the fasting snack decreased hunger and increased a sense of satiety at hour 12. The majority felt that the fasting snack also had a favorable impact on their ability to complete the 14-h fast.,There were no reports of adverse events or other safety or tolerability findings.