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#Grand Rounds

Results from the TEMPO Diet Trial: What are the Long-term Effects of Severe Energy-Restriction for Women with Postmenopausal Obesity?

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BACKGROUND AND PURPOSE:

  • Seimon et al. (JAMA Network Open, 2019) compared the long-term effects of severe vs moderate energy restriction in postmenopausal women with obesity

METHODS:

  • 12-month, single-center, randomized clinical trial (RCT)
  • Setting
    • The Type of Energy Manipulation for Promoting Optimum Metabolic Health and Body Composition in Obesity (TEMPO) Diet Trial
    • Participants recruited from the Sydney, Australia area
  • Postmenopausal women
    • 45 to 65 years | BMI 30 to 40 | ≥5 years postmenopausal | <3 hours of structured physical activity per week
  • Groups
    • Moderate intervention
      • 12 months of moderate (25%-35%) energy restriction with a food-based diet
    • Severe intervention
      • 4 months of severe (65%-75%) energy restriction with a total meal replacement diet | Followed by 8 months of moderate energy restriction
    • Both groups had a protein intake of 1.0 g/kg of actual body weight per day
    • Physical activity “was encouraged but not supervised”
  • Primary outcome
    • Whole-body lean mass ≥12 month after beginning of intervention
  • Secondary outcomes (all measured at 0, 4, 6, and 12 months)
    • Body weight
    • Thigh muscle area and muscle function (strength)
    • Bone mineral density (BMD)
    • Fat mass and distribution

RESULTS:

  • A total of 101 participants
    • Mean age, 58.0 years | Mean BMI 34.4
  • Compared with the moderate group at 12 months, the severe group
    • Lost more weight
      • Effect size: −6.6 kg (95% CI, −8.2 to −5.1 kg)
    • Lost more whole-body lean mass
      • Effect size: −1.2 kg (95% CI, −2.0 to −0.4 kg)
    • Lost more thigh muscle area
      • Effect size: −4.2 cm2 (95% CI, −6.5 to −1.9 cm2)
    • Note: Strength was not affected
  • Compared with moderate group, the estimated marginal mean weight loss at 12 months was significantly greater in the severe group (P < .001)
    • Severe: −15.3 (95% CI, −18.1 to −12.5kg)
    • Moderate: -8.4 (95% CI, −11.4 to −5.4 kg)
  • At 12 months, a greater percentage of participants in the severe group had lost ≥10% of their baseline weight (P < .001)
    • Severe: 89.1%
    • Moderate: 35.9%
    • In addition, the severe group had a comparatively healthier fat distribution with loss of more whole-body fat mass, abdominal subcutaneous adipose tissue and visceral adipose tissue
    • However, women in the severe group also lost more total hip BMD
      • Effect size of BMD loss: −0.017 g/cm2 (95% CI, −0.029 to −0.005 g/cm2)

CONCLUSION:

  • This trial demonstrated that compared to moderate restriction, a severe energy-restriction diet was associated with a 2-fold greater weight and fat loss over 12 months in postmenopausal women
    • However, hip bone mineral density was impacted
  • The authors suggest being cautious in using severe dietary restriction in women have osteopenia or osteoporosis

However, this bone loss must be considered in light of the beneficial effects of substantial weight loss on other health outcomes and health care costs

Learn More – Primary Sources:

Effect of Weight Loss via Severe vs Moderate Energy Restriction on Lean Mass and Body Composition Among Postmenopausal Women With Obesity: The TEMPO Diet Randomized Clinical Trial

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