Ad-Libitum Paleo Diet W/ a Handful of Simple Rules Cuts 5-7 kg of Body Fat in 12 Weeks - Plus: Paleo Research Overview

Yes, these foods were "allowed" - Even nuts, albeit in limited amounts.
Ok, I have to admit that I have repeatedly made fun of "paleo" in the past. Its "cultish", sometimes even "sectarian" appeal is and will remain as hilarious in my eyes as the (for some people life-or-death-)question whether certain foods "are paleo" or not (who cares, as long as they are healthy?). If you happen to have seen my presentation at the Paleo Convention in Berlin, last year, you will know that, despite my apathy against the quasi-religious sides of "paleo", I do appreciate a certain set of "rules" or "principles" (or whatever you may call them) all iterations of "paleo" have in common.

These principles work! And they have just been shown to help middle-aged type II diabetics (age 59±8 years) shed a quite impressive 6.7 kg of body fat (w/out exercise "only 5.7kg) in 12 weeks - without dieting as in not eating, although you're hungry (Otten. 2016).
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As the headline already tells you, the subjects, individuals diagnosed with type 2 diabetes within the past 10 years, who had a BMI of 25–40 kg/m2 and were weight stable (i.e. <5% weight loss) for 6 months (that's important, because otherwise the data on the energy deficit in Figure 1, which was calculated as baseline vs. study intake would be inaccurate) were allowed to eat "as-libitum", which practically means "as much as they wanted", as long, as they adhered to (a) "paleo foods", i.e. lean meat, fish, seafood, eggs, vegetables, fruits, berries, and nuts, but no cereals, dairy products, legumes, refined fats, refined sugars, and (extra) salt (canned fish and cold cuts like ham were allowed) and (b) followed the following simple food-specific rules:
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    eggs - maximally 1–2/day, and no more than 5/week,
  • potatoes - only 1 medium sized potato per day
  • dried fruit - 130 g/day, not more,
  • nuts - 60 g/day, so no snacking on almonds 24/7
  • rapeseed or olive oil - maximum 15 g/day
  • honey and vinegar - only small amounts as flavoring in cooking
  • coffee & tea - max 300 ml/day (each, I assume)
  • red wine - only one glass per week
Since the participants were also instructed to drink mainly still water, you will probably not be surprised that all subjects, irrespective of whether they had been randomly assigned to the no exercise or exercise group ended up in a significant energy deficit - in spite of being allowed to eat "ad-libitum" (see Figure 1 for the most relevant information about their diet(s)).
Figure 1: Energy and macronutrient intake; differences, rel. + abs. above bars (Otten. 2016).
It is also not surprising that the extra-exercise (1h of exercise, 3x per week | details see blue box below) that was done on top of the (at least) 30 min of moderate intensity exercise like brisk walking all patients had been prescribed as part of their regular T2DM treatment, almost doubled the energy deficit of the subjects in the paleo + exercise, i.e. the PD-EX group (remember: the subjects were allowed to eat more, as long as they stuck to the previously presented rules - since the intake of foods like steak or chicken breast was not limited, they would have been able - within certain limits - to significantly increase their energy intake and still did not fully compensate the energy expended during the workouts; this should remind you of previous articles of mine outlining that "exercise does not just make you hungry" | learn more)
What about compli-ance? Both groups increased their relative intake of protein and their intake of monounsatu-rated and polyunsatu-rated fatty acids. Both groups lowered their intake of carbohydrates and saturated fatty acids. The reduction of sodium intake was only significant in the PD-EX group. Nine of the 14 participants in the PD-EX group completed the 36 exercise sessions according to the study protocol. The remaining five participants completed between 27 and 35 workouts during the study period. The participants in the PD-EX group increased the cumulative weight load (weight × repetitions × sets) with the leg press during one exercise session from 1350 kg (900−1800) to 3000 kg (2700−4000) after 12 weeks.
What did the 1h workouts look like? The PD-EX group underwent a program comprising a combination of aerobic exercise and resistance training in 1-h sessions three times weekly at the Sports Medicine unit at Umeå University. The exercise sessions were performed on weekdays, with at least 1 day of rest between sessions. They were supervised by experienced personal trainers with bachelor’s degrees in Sports Medicine.
All exercise sessions started with aerobic exercise. The first session of each week consisted of low-intensity aerobic training at 70% of the maximum heart rate on a crosstrainer (Monark Prime, XT 50, Vansbro, Sweden). The second session of the week consisted of ten high-intensity sprint intervals at 100% of the maximal workload on a cycle-ergometer (Monark, Ergomedic 839E, Vansbro, Sweden), with low-intensity cycling between the sprints. The third session of each week comprised six moderate-intensity 5-min intervals between 45 and 60% of maximal workload on a cycle-ergometer. The duration/workload of the intervals increased every other week. When necessary, the intensity of the aerobic exercise sessions was adjusted in accordance with the participant’s performance.
After the aerobic exercise, the sessions progressed to resistance training with both upper and lower body exercises, including leg presses, seated leg extensions, leg curls, hip raises, flat and incline bench presses, seated rows, dumbbell rows, lat pull-downs, shoulder raises, back extensions, burpees, sit-ups, step-ups, and wall ball shots. At each training session, the participant performed 3–5 of the aforementioned resistance exercises, with 10–15 repetitions and 2–4 sets. Once participants could complete all repetitions, the workload was increased for the following session.
Still, the main advantage of exercise was not, as you may now falsely expect due to the ~100% increase in energy deficit, a significantly increased loss of body fat (the latter did not double and that must not surprise you!). Neither was it a powerful increase in insulin sensitivity (HOMA-IR), which increased in both groups similarly (45% | p<0.001). Yeah, and even the extra 0.2% decrease in HbA1c, the sugar coating on the subjects' red blood cells  (-0.9% in diet only, -1.1% in diet + exercise), is not the main reason you must not miss your workouts while dieting (paleo-style or not ;-).
Figure 2: Fat mass (a), insulin sensitivity (b), and cardiovascular fitness (c and d) during 12 weeks following either a Paleolithic diet with a supervised exercise program (PD-EX) or a Paleolithic diet combined with general exercise recommendations (PD). Boxes represent medians and IQRs, whiskers represent the most extreme values besides outliers, and filled circles represent outliers (>1.5 IQR); **p<0 .01="" 2016="" p="" td="" tten.="">
So why are workouts important, then? It's the increased fitness, as evidenced by the PD-EX exclusive increase in maximum oxygen uptake (0.2 L/min) and the conservation of lean mass, which reached statistical significance (1.2kg in PD-EX vs. 2.6 kg in PD) only in the male subjects (p<0.05 for the difference between intervention groups), however (it is well possible that this is due to a lack of protein in the women's diet, cf. bottom line), that made / makes exercise (esp. resistance training) so valuable while dieting... this and another thing, the abstract of the study does not appreciate, because it did not reach statistical significance: The increase in relative resting energy expenditure (REE), the scientists observed in the PD-EX group (this adds to the extra energy expenditure during workouts, by the way!). While the relative REE didn't change in the PD group, it increased by a(n over the long-term) potentially relevant (but statistically non-significant) 3% in the PD-EX group - an effect that more than countered the nasty reduction in REE scientists still hold responsible for the yoyo-effect most "biggest losers" experience after successfully losing weight.
Is this the first paleo study? Even though, the number is still low, this is not the first one. In 2009, already, Jönssen et al. reported that "a 3-month study period, a paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a diabetes diet in patients with type 2 diabetes" (Jönssen. 2009). In 2013, the same authors found that a "Paleolithic diet is more satiating per calorie than a diabetes diet in patients with type 2 dia-betes [and that t]he Paleolithic diet was seen as instrumental in weight loss, albeit it was difficult to adhere to" (Jönssen. 2013) - a result they had previously observed in patients with heart disease, too, when they compared a paleo to a Mediterranean diet (Jönssen. 2010), which also improve glucose tolerance less effectively than the paleo diet in said subject group (Lindeberg. 2007). Furthermore, studies in healthy individiuals Frassetto et al. (2015) like Österdahl et al. report that even "a short-term intervention showed some favourable effects by the diet" (Österdahl. 2008) such as weight loss, waist reductions and an improved quality of the diet and improved "BP [blood pressure] and glucose tolerance, decreases insulin secretion, increases insulin sensitivity and improves lipid profiles without weight loss" (Frassetto. 2015). In view of the fact that the less than a handful of long-term (>1 year), studies similar benefits when comparing paleo to other recommended diets, such as the Nordic Nutrition Recommendations in Mellbert et al. (2014) also show "greater beneficial effects" (e.g. fat mass, abdominal obesity and triglyceride levels just as they were observed by Ryberg, et al. in 2013) for the paleo diet(s), one could argue that the evidence in favor of paleo dieting in health and disease is slowly accumulating.
Eventually, diet is king, ... and that, just like the fact that doubling the energy deficit you have on paper won't double the loss of fat mass, shouldn't be news to you. That doesn't mean that dieting with exercise would not increase the loss of fat mass, but what is more important is that it helped the subjects - at least the male ones - maintain significantly more lean mass (=muscle and organ mass, which also affects you REE!).

Whether the failure of the workout to produce significant lean mass maintenance in the women was due to their sex, their hormonal status (the females included in the study were postmenopausal) or the fact that they gravitated to eat less protein (this is speculative, since the study does not provides sex-specific intakes) cannot be said. Even in the men, the lean mass loss is yet large enough to speculate that we'd have seen sign. less muscle loss with higher protein intakes. After all, the 79g the subjects in the PED-EX group consumed on a daily basis amount to only 0,84g protein per kg of body weight. This has repeatedly been shown to be too little for older individuals - even if they were not dieting. A follow up to the study which includes (a) simply more protein or (b) an extra protein shake after the workouts that would bump the subjects' total protein intake into the ~1.6-2.0g/kg region would thus be something I'd like to see in the (not so distant) future.
As long as said study will not have been done, though (something tells me that it won't ;-), you can still reference Otten's study as evidence that you can effectively lose weight without cereals, dairy products, and legumes... I have to admit, though, that I suspect that especially the latter two of these "forbidden" foods would rather have augmented, not messed with the improvements in body composition Otten et al. observed in the study at hand | Comment!
  • Frassetto, Lynda A., et al. "Metabolic and physiologic improvements from consuming a paleolithic, hunter-gatherer type diet." European journal of clinical nutrition 63.8 (2009): 947-955.
  • Jönsson, Tommy, et al. "Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study." Cardiovasc Diabetol 8.35 (2009): 1-14.
  • Jönsson, Tommy, et al. "A paleolithic diet is more satiating per calorie than a mediterranean-like diet in individuals with ischemic heart disease." Nutrition & metabolism 7.1 (2010): 1.
  • Jönsson, Tommy, et al. "Subjective satiety and other experiences of a Paleolithic diet compared to a diabetes diet in patients with type 2 diabetes." Nutrition journal 12.1 (2013): 1.
  • Mellberg, Caroline, et al. "Long-term effects of a palaeolithic-type diet in obese postmenopausal women: a two-year randomized trial." European journal of clinical nutrition 68.3 (2014): 350.
  • Lindeberg, Staffan, et al. "A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease." Diabetologia 50.9 (2007): 1795-1807.
  • Österdahl, M., et al. "Effects of a short-term intervention with a paleolithic diet in healthy volunteers." European journal of clinical nutrition 62.5 (2008): 682-685.
  • Otten, J, et al. "Effects of a Paleolithic diet with and without supervised exercise on fat mass, insulin sensitivity, and glycemic control: a randomized controlled trial in individuals with type 2 diabetes." Diabetes/Metabolism Research and Reviews (2016 |Accepted Article). doi: 10.1002/dmrr.2828
  • Ryberg, Mats, et al. "A Palaeolithic‐type diet causes strong tissue‐specific effects on ectopic fat deposition in obese postmenopausal women." Journal of Internal medicine 274.1 (2013): 67-76.
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